FDA 510(k) clearances — page 974
clearances on record, most recent first.
Clearances — page 974
97,301–97,400 of 175,890- K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER
- K962971 — POLYPROPYLENE MESH (VARIOUS SIZES)
- K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER
- K955067 — CLEARVIEW C. DIFF A
- K961359 — LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2
- K961449 — TRACHEOSTOMY TUBES TRACOE-FLEX
- K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES
- K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
- K962671 — STA-VWF CALIBRATOR KIT
- K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE
- K962819 — GENTAMICIN FLEX REAGENT CARTRIDGE
- K962820 — CARBAMAZEPINE FLEX REAGENT CARTRIDGE
- K963070 — VENIPUNCTURE KIT
- K963088 — SHEATH, ELECTROSURGICAL PENCIL
- K963267 — VANCOMYCIN FLEX REAGENT CARTRIDGE
- K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
- K954168 — E100A PULSE OXIMETER FINGER SENSOR/PROBE
- K955012 — MIZUHO RADIOLUCENT HEAD FRAME
- K960192 — POSITRON COINCIDENCE DETECTION
- K960836 — DMS-9000
- K960965 — FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
- K961039 — BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL
- K961376 — SMART-TENS, MODEL 456
- K961466 — PERCUTANEOUS INTRODUCER SET
- K961980 — BIPORE BALLOON DILATATION CATHETER
- K962218 — CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
- K962274 — UNICAP 100
- K962329 — GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10
- K962428 — EBS (ESPE BONDING SYSTEM)
- K962495 — INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
- K962513 — DERMAPLEX HYDROGEL WOUND DRESSING
- K962520 — DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A
- K962540 — E-TYPE CONTRA ANGLE NAC-E
- K962836 — HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
- K962853 — NEOSONO
- K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
- K960772 — PHOTODERM PL.
- K961006 — MEDLITE/755 ALEXANDRITE LASER SYSTEM
- K961629 — THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
- K961800 — HEAD MOUNTED DISPLAY
- K962104 — AIRLIFT BALLOON RETRACTON SYSTEM
- K962255 — CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
- K962258 — ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
- K962313 — MODIFIED LEVEEN NEEDLE ELECTRODE
- K962330 — AMO ARTHOSCOPES
- K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASER
- K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
- K962440 — PERTAC II/PERTAC II APLITIP
- K962442 — HYTAC APLITIP/HYTAC OSB
- K962493 — ENDOSCOPIC CLIP APPLIER
- K962510 — HEARTPORT ENDOAORTIC CLAMP
- K962543 — ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
- K962800 — STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
- K963334 — JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
- K941782 — VENTANA ANTI-CD5 PRIMARY ANTIBODY
- K954350 — CARD GUARD MODEL CG-6500
- K955628 — FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
- K960875 — KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
- K961150 — DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
- K961420 — PROSTYLE COMPACT
- K961625 — QUATROLOC FEMORAL COMPONENT & HEAD
- K962026 — PREPOWDER VINYL PATIENT EXAMINATION GLOVES
- K962266 — 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
- K962267 — PERFECTA PS REVISION STEM
- K962342 — HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
- K962516 — TAP ANTI-SNORING DEVICE
- K962664 — ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
- K962712 — YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
- K962895 — DSL DHEA-S-7
- K963047 — AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)
- K963078 — STERI-OSS TEMPORARY IMPLANT CEMENT
- K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY)
- K963181 — ELECSYS CALCHECK T UPDATE
- K963191 — CEDIA ANTIBIOTIC TDM MULTI-CALS
- K952882 — PERSONAL TELEMEDICINE SYSTEM
- K953974 — CAMVISION 1000
- K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
- K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
- K961023 — AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
- K962118 — DSL ACTIVE FSH IRMA
- K962260 — REAL-TIME VIDEO CONTRAST ENHANCER
- K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP
- K962469 — ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
- K962487 — BREAST TREATMENT AID M200
- K962698 — ACUTEK'S CLEARPASAGE
- K962798 — AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
- K962961 — SUSTAINED PHONATION
- K963033 — BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
- K963346 — STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3
- K960457 — ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
- K961075 — MEDCARE REGIONAL ANETHESIA KIT
- K961832 — BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
- K962403 — NOBLEPHARMA WIDE ACCESSORIES
- K962449 — OSTEO COMPACTION KIT
- K962614 — SHIFA STERILE DISPOSABLE SYRINGES
- K962644 — VIGOR COMPRESSION HIP SCREW SYSTEM
- K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
- K962741 — TRI-PHASIX CHROMATIC ALGINATE
- K962851 — ACRYNOODLES ABSORBENT WOUND DRESSING
- K963122 — UNITRON MODEL ICON KR
Data sourced from openFDA. This site is unofficial and independent of the FDA.