FDA 510(k) clearances — page 821
clearances on record, most recent first.
Clearances — page 821
82,001–82,100 of 176,637- K001947 — T.I.M.S., VERSION 2.00
- K002024 — PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
- K002047 — DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
- K002266 — BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
- K002272 — BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
- K002337 — BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
- K002417 — BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D
- K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
- K002587 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
- K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
- K002672 — VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
- K002683 — WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
- K002778 — ENTERIC INJECTION CATHETER WITH IRRIGATION
- K002816 — TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
- K002860 — MODEL 6900GE-64: C-SPINE ARRAY
- K003063 — GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION
- K003142 — MICROMANIPULATOR
- K003197 — VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
- K003300 — MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
- K003302 — IM-5A INJECTOR
- K003303 — IM-5B MICROINJECTOR
- K003304 — IM-6 MICROINJECTOR
- K003306 — C. DIFFICILE TOX A/B II
- K003307 — DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W
- K003309 — DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
- K003321 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
- K003336 — MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K003353 — MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
- K003365 — S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
- K003370 — JAMSHIDI MARROW ACQUISITION CRADLE
- K003525 — VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
- K002089 — ROSETTA-LT/ROSETTA-RX
- K002214 — SINUSCOPE AND BACCESSORIES
- K002630 — PURESPERM WASH
- K002633 — SILMAX PECTORAL IMPLANT
- K002649 — ARAMIS DERMATOLOGICAL LASER
- K002703 — O-PERM 30
- K002725 — MICROPAQ, MODELS 402 AND 404
- K002806 — K-DEFIB/PACE, MODEL KDP-60A
- K002813 — NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
- K002864 — MODEL 6600GE-64: TRAMA NECK ARRAY
- K002961 — MINITUB MULTI-PURPOSE CASSETTES
- K003079 — SPECIALTY TINT SOFT CONTACT LENS
- K003109 — COMPLETE BRAND LUBRICATING AND REWETTING DROPS
- K003146 — CLINIFLO INCENTIVE SPIROMETER
- K003298 — MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
- K003317 — RENEW LS-1
- K003424 — PINNACLE R/O II OR RADIFOCUS INTRODUCER II
- K003444 — MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
- DEN000010 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- K002199 — MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
- K002605 — 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
- K002623 — PURESPERM 40 AND PURESPERM 80
- K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT
- K002644 — RADIAL HEAD IMPLANT
- K002731 — N LATEX B2-MICROGLOBULIN
- K002752 — BAYONET FORCEPS BIPOLAR IRRIGATING
- K003098 — ACCESS ULTRASENSITIVE HGH CALIBRATORS
- K003184 — RS BIOTECH GALAXY 'R' CO2 INCUBATOR
- K003471 — MAGNA TEK ESU-400
- K001544 — VAGINAL APPLICATOR SHIELDED
- K002586 — MEDPOR PTERIONAL SURGICAL IMPLANT
- K002595 — CBS STRAW
- K002597 — CN ACQUISITION STATION
- K002692 — DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
- K002709 — RACE ENDODONTIC FILE
- K002724 — NUMALINK
- K002780 — VIATRONIX VISUALIZATION SYSTEM (VVS)
- K002786 — BIOSENSORS CENTRAL VENOUS CATHETER KITS
- K002840 — MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
- K003007 — GALAXY
- K003132 — DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
- K003335 — RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
- K003408 — CT CORD IQ OPTION 1.0
- K992529 — TISSUE SPECTROSCOPE
- K000253 — SILENT NIGHT V
- K001663 — FRONT-LOAD POLYPROPYLENE SYRINGE
- K002080 — BEHRING COAGULATION SYSTEM, MODEL BCS
- K002447 — MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
- K002571 — MULITPLE MALE LATX CONDOM
- K002572 — MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
- K002573 — ADVANCED UROSCIENCE INNERSHEATH
- K002584 — ECAT ACCEL PET SCANNER
- K002608 — INVAC
- K002619 — NEWGEN SYSTEM
- K002620 — SURESMILE SYSTEM
- K002774 — HRH-63 HEAD ARRAY COIL
- K002859 — SSW-STERILE SOLUTION WARMER
- K002935 — SYNTHES 1.5MM TI BROW LIFT SCREW
- K002993 — HERACERAM
- K003261 — CREATININE PLUS
- K003399 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
- K003434 — ALLEGRO TB, ALLEGRO N
- K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
- K001841 — 35/CD CINECONVERTER
- K002575 — INTER-OP DURASUL ACETABULAR INSERTS (4MM)
- K002600 — LITWIN CRUICATE ANCHOR
- K002843 — SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
- K003153 — SOLOBOND PLUS
- K000654 — VBMAX
Data sourced from openFDA. This site is unofficial and independent of the FDA.