FDA 510(k) clearances — page 1321
clearances on record, most recent first.
Clearances — page 1321
132,001–132,100 of 175,890- K892000 — FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE
- K892096 — PATIENT EXAMINATION GLOVE (LATEX)
- K892115 — PROTEX PATIENT EXAMINATION GLOVES (LATEX)
- K892262 — FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
- K881164 — LEUNOMED RFB 5000
- K882980 — REBUILDER BUCKET SYSTEM
- K885146 — CL UNIVERSAL HIP DEVICE
- K890420 — USCI 7F GUIDE CATHETER
- K891267 — PATIENT EXAMINATION GLOVES (LATEX)
- K891345 — MOBILIMB CPM SHOULDER UNIT
- K892343 — SUCTION CONTROL VALVE
- K882610 — COOK-GIANTURCO BILIARY Z STENT
- K883948 — MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
- K884354 — IMAGER FLUSH CATHETERS
- K884797 — BERICHROM ALPHA-2-ANTIPLASMIN
- K884841 — RETRACTABLE PISTON SYRINGE W/LUER-LOCK COLLAR
- K890126 — KAMED STETHOSCOPE
- K890134 — FTK FECAL TRANSPORT KIT
- K890401 — GOLDEN MEAN MACHINE(TM) (CLASS 2)
- K890466 — SIGMOID TONOMITOR
- K890484 — HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE
- K890518 — SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM
- K890522 — PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
- K890527 — ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
- K890633 — ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
- K890634 — BERICHROM PROTEIN C KIT
- K890751 — ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT
- K890775 — INFRALASE - LASERGUIDE DELIVERY SYSTEM
- K890859 — EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
- K891072 — INTRAVASCULAR ADMINISTRATION SET
- K891337 — THROMBOSCREEN APTT REAGENT
- K891370 — EDL ONE-STAGE PROTHROMBIN TIME REAGENT
- K892004 — LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3
- K892231 — V-TREND TARGET CRP TEST
- K883782 — BELZER UW-CSS
- K884231 — SURGICAL 'LASER' DRAPE
- K884598 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200
- K884633 — ARISTA AND ORIENT SURGICAL GLOVES
- K890330 — MEDILOG 6000-FD REPORT GENERATOR
- K890459 — JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES
- K890606 — OHMEDA 5330 AGENT MONITOR
- K890795 — RESPIRONICS SEALEASY II
- K891293 — SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
- K891621 — STERILE SURGEONS' GLOVES
- K891677 — COATED ISOLATION GOWN
- K892118 — NON-STERILE MASKS AND CAPS
- K883969 — UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
- K884327 — EXCEL Y-CONNECTOR CAT. #E-201
- K884697 — HEPARIN BONDING FOR CATHETERS
- K884938 — VITAL SIGNS MONITOR
- K885036 — POROUS COATED GENESIS FEMORAL COMPONENT
- K885054 — SYSTEM SEVENTY SEVEN
- K885201 — OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
- K885204 — HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
- K890282 — RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
- K890285 — PROSTHETIC CEMENT REMOVER
- K890338 — MEDILOG EDITOR
- K890425 — NEOTECH MUCUS TRAP W/CATHETER
- K890580 — LIPID STOPCOCK
- K890725 — PHOTOCHROMIC LENS
- K890735 — COATED APEX PROBE
- K890841 — TITANIUM STAPLES
- K891104 — CD TELEMETRY SYSTEMS
- K891597 — NOSEY SHADES (SUNGLASSES) NONPRESCRIPTION
- K891756 — KINETIC MODEL 500
- K891757 — KINETIC MODEL 1000
- K891758 — KINETIC MODEL 132
- K891759 — KINETIC MODEL 330
- K891983 — CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
- K884206 — HEMAWIPE SYSTEM, THE CIVILIZED TEST
- K884913 — MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
- K890053 — MARDX LYME DISEASE IGG IFA TEST SYSTEM
- K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
- K890615 — DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
- K890773 — HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
- K890976 — PATIENT EXAMINATION GLOVE
- K891141 — CARERITE FACE MASK
- K891155 — IRON REAGENT
- K891385 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
- K891537 — CORE BIOPSY NEEDLE, CATALOG CODE #54006
- K891589 — 3MM DISPOSABLE SPECULA
- K882572 — DOCTOR KOLYNOS TOOTHBRUSH
- K884097 — MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES
- K884166 — DICOR CERAMIC INLAY - NEW TECHNIC
- K884672 — APEX 115 NUCLEAR MEDICINE PROCESSOR
- K884674 — APEX 415 ANGER CAMERA
- K884675 — APEX 609R ANGER CAMERA
- K885325 — FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
- K890029 — HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
- K890300 — INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
- K890306 — BCM-ARC 105 X-RAY MOBILE UNIT
- K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR
- K890608 — FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT
- K890623 — FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT
- K890656 — LIP BUMPER
- K890668 — CLEAN DENT
- K890729 — SUTURE REMOVAL KIT
- K890829 — UNIFAST LC
- K890850 — CENTURY DISOSABLE LATEX GLOVE
- K890940 — MODIFIED LABELING FOR POLYDERM WBC(TM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.