FDA 510(k) clearances — page 1355

176,637 clearances on record, most recent first.

Clearances — page 1355

135,401–135,500 of 176,637

K883341 — HEARTSTART 1000Laerdal Mfg. Corp.·Product code MKJ·1988-09-12
K883344 — HEARTSTART 1000SLaerdal Mfg. Corp.·Product code MKJ·1988-09-12
K883431 — RAYMAX 2100 MODELS 2130 & 2136Raymax Medical Corp.·Product code IZO·1988-09-12
K883575 — MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USESite Microsurgical Systems, Inc.·Product code HMG·1988-09-12
K881320 — URINE TOXICOLOGY STANDARDVerichem Laboratories, Inc.·Product code DKB·1988-09-09
K881616 — PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1Progress Mankind Technology·Product code JXG·1988-09-09
K881631 — BIODYNAMICS AUTOTRANSFUSION RESERVOIRBiodynamics Corp.·Product code CAC·1988-09-09
K882002 — PREGNAGEN(TM)Biogenex Laboratories·Product code JHI·1988-09-09
K882379 — MINIM-X 2001-CIAS & MINIM-X 2002-CIASDentomar, Inc.·Product code EAP·1988-09-09
K882403 — OPHTHALMIC FLUID INJECTORTrek Medical Products, Inc.·Product code FMF·1988-09-09
K882506 — MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0Span-America Medical Systems, Inc.·Product code KMJ·1988-09-09
K882536 — OPHTHALMIC PAO VALVELook, Inc.·Product code FMF·1988-09-09
K882647 — GESCO CATHETERIZATION TRAYGesco Intl., Inc.·Product code GBQ·1988-09-09
K882734 — KTP/YAG(TM) SURGICAL LASERLaserscope·Product code GEX·1988-09-09
K882926 — MODEL AU-1 ACCESSORY UNITDirected Energy, Inc.·Product code GEX·1988-09-09
K882938 — STAT FAX(TM)Awareness Technology, Inc.·Product code JJQ·1988-09-09
K882941 — BLOOD GAS MIXTURESwisco, Inc.·Product code CHL·1988-09-09
K883012 — A.QC CHEMISTRY CONTROL LEVEL 2Arden Medical Systems, Inc.·Product code JJY·1988-09-09
K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASSerono Diagnostics, Inc.·Product code KHQ·1988-09-09
K883190 — DADE TDM CONTROLBaxter Healthcare Corp·Product code DIF·1988-09-09
K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALTElectro-Nucleonics, Inc.·Product code CKA·1988-09-09
K883206 — LACTATE DEHYDROGENASE LDHElectro-Nucleonics, Inc.·Product code CFJ·1988-09-09
K883279 — PHASE II FSH KITVitek Systems, Inc.·Product code CGJ·1988-09-09
K883459 — DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5Diagnostic Products Corp.·Product code JXM·1988-09-09
K881412 — MYOCARD BIOPSY FORCEPFehling Medizintechnik GmbH·Product code DWZ·1988-09-08
K881519 — VAC-G (GUILLOTINE VITRECTOR)B&B Medical Assoc., Inc.·Product code HQE·1988-09-08
K881701 — RADKOR SFC-21Radkor, Inc.·Product code IYB·1988-09-08
K882015 — TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEMUltramed, Inc.·Product code IYN·1988-09-08
K882451 — OLYMPUS REPLY CHEMISTRY ANALYZEROlympus Corp.·Product code JJE·1988-09-08
K882477 — ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANELPasco Laboratories, Inc.·Product code JWY·1988-09-08
K882552 — METATECH ROBINSON BOLT ACCESSORYMetatech Corp.·Product code GWM·1988-09-08
K882737 — ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCERAcuson Corp.·Product code IYN·1988-09-08
K883096 — TRACHEAL TUBE LASER SHIELD KITAmerical Corp.·Product code BTR·1988-09-08
K883160 — CATAPULT BUCKY (KATAPULT BLENDA)Bay X-Ray, Inc.·Product code KPR·1988-09-08
K880973 — MICROLYTE 7The Rupp & Bowman Co.·Product code JFP·1988-09-07
K881520 — VAC (OSCILLATING VITRECTOR)B&B Medical Assoc., Inc.·Product code HQE·1988-09-07
K882579 — HEMATRAK(R) MODEL 590Priority Service Systems·Product code GKZ·1988-09-07
K882612 — SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERBaker Instructions Corp.·Product code GKZ·1988-09-07
K882998 — ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TESTAmtec Diagnostics International, Inc.·Product code DCK·1988-09-07
K883076 — GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELSBaxter Healthcare Corp·Product code JWY·1988-09-07
K883232 — HISTONE REACTIVE ANAVal Tech Diagnostics, Inc.·Product code LLL·1988-09-07
K883273 — DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)3M Company·Product code DHB·1988-09-07
K883349 — QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JZT·1988-09-07
K883355 — UBI MAGIWEL RF-IGM QUANTITATIVEUnited Biotech, Inc.·Product code DHR·1988-09-07
K883385 — RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TESTLos Alamos Diagnostics·Product code JXA·1988-09-07
K883394 — GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELSBaxter Healthcare Corp·Product code JWY·1988-09-07
K883491 — TECHNICON DPA-1 APOLIPOPROTEIN BTechnicon Instruments Corp.·Product code MSJ·1988-09-07
K883494 — TECHNICON DPA-1 IMMUNOGLOBULIN GTechnicon Instruments Corp.·Product code DAH·1988-09-07
K883536 — QM300 RHEUMATOID FACTOR ANTIGEN PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DHR·1988-09-07
K883538 — QM300 CALIBRATOR E PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DHR·1988-09-07
K883623 — EX-CELL 300TM, CATALOG NO. 200-3600J R Scientific·Product code KIT·1988-09-07
K883624 — EX-CELL 300TM, CATALOG NO. 200-3601J R Scientific·Product code KIT·1988-09-07
K883625 — EX-CELL 301, CATALOG NO. 200-3651J R Scientific·Product code KIT·1988-09-07
K883626 — EX-CELL 301, CATALOG NO. 210-3577J R Scientific·Product code KIT·1988-09-07
K883627 — MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150J R Scientific·Product code KIT·1988-09-07
K883628 — MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051J R Scientific·Product code KIT·1988-09-07
K883629 — HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013J R Scientific·Product code KIT·1988-09-07
K883630 — RPMI-1640 MEDIUM, CATALOG NO. 210-3525J R Scientific·Product code KIT·1988-09-07
K883631 — EX-CELL 300TM, CATALOG # 210-3579J R Scientific·Product code KIT·1988-09-07
K883632 — EX-CELL 300TM, CATALOG NO. 210-3575J R Scientific·Product code KIT·1988-09-07
K880534 — ZEPHYRRacal Health & Safety, Inc.·Product code FXX·1988-09-06
K880725 — SAM(TM) MODEL ONESentel Tech. C/O Criticare Systems, Inc.·Product code BZQ·1988-09-06
K880923 — PATIENT VENTILATOR ISOLATORDryden Corp.·Product code CBK·1988-09-06
K881893 — NUMED BALLOON THERMODILUTION CATHETERNuMED, Inc.·Product code KRB·1988-09-06
K881984 — EOL, MODEL LIOEol, Inc.·Product code HLI·1988-09-06
K882145 — PHOTO-CURING LIGHTDentsply Intl.·Product code EBZ·1988-09-06
K882330 — BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETERC.R. Bard, Inc.·Product code LDF·1988-09-06
K882407 — BOW & ARROW DRILL GUIDEInstrument Makar, Inc.·Product code LXI·1988-09-06
K882422 — DISPOSABLE ARACHNOID KNIFEMicrobio-Medics, Inc.·Product code HAO·1988-09-06
K882442 — RK2000 K-THERMIA SYSTEMBaxter Healthcare Corp·Product code DWJ·1988-09-06
K883153 — UNDISTAT WITH EXPLORATOR 35 (UCS 35E)Bay X-Ray, Inc.·Product code IXR·1988-09-06
K883154 — SELDIX 325 TWO PULSE GENERATOR/CONTROLBay X-Ray, Inc.·Product code IZO·1988-09-06
K883155 — RASTIX X-RAY TABLEBay X-Ray, Inc.·Product code KXJ·1988-09-06
K883162 — TELESTATIX X-RAY TABLEBay X-Ray, Inc.·Product code IXR·1988-09-06
K883203 — MODEL 5866-34A PACEMAKER LEAD ADAPTORMedtronic Vascular·Product code DTB·1988-09-06
K883424 — SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TABIntera Corp.·Product code KKX·1988-09-06
K883512 — HERAEUS WHITEDegussa Dental, Inc.·Product code EJS·1988-09-06
K883602 — BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEADIntermedics, Inc.·Product code DTB·1988-09-06
K874288 — PHADEBACT ETEC-LT TESTPharmacia, Inc.·Product code GNA·1988-09-02
K875285 — MULTI-CHEMISTRY LINEARITY STANDARDVerichem Laboratories, Inc.·Product code JIX·1988-09-02
K881674 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TCShimadzu Precision Instruments, Inc.·Product code JAK·1988-09-02
K881696 — RADKOR XG-325Radkor, Inc.·Product code IZO·1988-09-02
K881700 — RADKOR KOB-84Radkor, Inc.·Product code KXJ·1988-09-02
K882329 — L-F COILED EXTENSION TUBINGMallinckrodt Group, Inc.·Product code DXT·1988-09-02
K882365 — HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900Heraeus Lasersonics, Inc.·Product code GEX·1988-09-02
K882433 — LARYNGOSCOPE RIGIDEastmed Enterprises, Inc.·Product code CCW·1988-09-02
K882496 — ABUSCREEN(R) ONTRAK(TM) FOR MORPHINERoche Diagnostic Systems, Inc.·Product code DJG·1988-09-02
K882602 — STACHROM ANTIPLASMIN TEST KITAmerican Bioproducts Co.·Product code GGP·1988-09-02
K882603 — STACHROM ANTIPLASMIN CONTROLAmerican Bioproducts Co.·Product code GGP·1988-09-02
K883020 — RFA-300 RAPID FLOW ANALYZER W/COMPUTERAlpkem Corp.·Product code JJF·1988-09-02
K883081 — RADKOR, XG-515Radkor, Inc.·Product code IZO·1988-09-02
K883433 — AMBU TWIN PUMP - (MANUAL SUCTION PUMP)Ambu, Inc.·Product code GCY·1988-09-02
K883521 — C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYSPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1988-09-02
K883527 — GRID/RADIOGRAPHICUmi, Inc.·Product code IXJ·1988-09-02
K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)Innovative Medical Systems, Inc.·Product code IEO·1988-09-02
K880857 — SYRINGE PUMP MS2000Smash Ent., Inc.·Product code FRN·1988-09-01
K880878 — CX250 MOBILE GAMMA CAMERA & DCS CONSOLEPhilips Medical Systems (Cleveland), Inc.·Product code IYX·1988-09-01
K881662 — EXPANDED CLAIMES TO OSTEOGEN(R)Impladent·Product code DZE·1988-09-01
K882757 — ARGYLE AUTOTRANSFUSION BAGSherwood Medical Co.·Product code CAC·1988-09-01
K883513 — HEARING AID, UNITRON MODEL VISTA 1000Unitron Industries, Inc.·Product code ESD·1988-09-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.