FDA 510(k) clearances — page 902
clearances on record, most recent first.
Clearances — page 902
90,101–90,200 of 175,890- K974792 — CS/3(TM) MONITORS*
- K980829 — 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
- K980838 — REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM
- K980843 — EXETER INTRAMEDULLARY BONE PLUG
- K981014 — ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
- K981021 — ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
- K964332 — EAGLE CENTURY STEAM STERILIZER
- K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
- K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
- K973936 — FOCUS RTP SYSTEM
- K974106 — ICON IMPLANT SYSTEM
- K974812 — COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
- K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- K980826 — EQUIDOSE SOLID STATE DIODE DETECTORS
- K980952 — SNORE-CURE ANTI-SNORING APPLIANCE
- K981062 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
- K981139 — ETEST CEFTRIAXONE
- K981159 — PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
- K981230 — ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
- K981370 — MIRACLE MIX CAPSULE
- K981398 — ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
- K981555 — DIASCREEN REAGENT STRIPS
- DEN980001 — DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND
- K974678 — B-D AUTO-INJECTOR
- K974771 — STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
- K980342 — ETEST CHLORAMPHENICAL
- K980348 — ETEST VANCOMYCIN
- K980780 — DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
- K980801 — J-FX BIPOLAR HEAD
- K980886 — BABYTHERM 8000 LDR
- K980994 — IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
- K981113 — PEDIATRIC PRC
- K981201 — OSTEOLOCK ACETABULAR CUP
- K981240 — CREATININE (CREA)
- K981296 — GEEN MEDISOX
- K981388 — MICRO-STRIP FOR COCAINE METABOLITES
- K981389 — DISPOSABLE RE-NEW FORCEPS
- K981489 — UROSURGE SPIRASTENT PLUS URETERAL STENT
- K981491 — UROSURGE FILASTENT URETERAL STENT
- K981700 — VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
- K972502 — SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
- K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
- K974285 — PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
- K980338 — ETEST OFLOXACIN
- K980431 — SURGISIS
- K980558 — PAINBUSTER INFUSION SYSTEM
- K980763 — LYSONIX LIPOPLASTY ACCESS PORT
- K980961 — CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
- K980992 — IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
- K981012 — AIA-PACK MYOGLOBIN ASSAY
- K981134 — ETEST TETRACYCLINE
- K981250 — LICEMEISTER COMB
- K981512 — ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
- K981584 — ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
- K981585 — ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
- K980192 — MANAN NEPHROSTOMY DRAINAGE CATHETER
- K980193 — MANAN GENERAL UTILITY DRAINAGE CATHETER
- K980345 — ETEST CEFTRIAXONE
- K980347 — ETEST TETRACYCLINE
- K980407 — HOPE NEBULIZER
- K980766 — OSTEONICS ANTEVERTED NECK HA HIP STEMS
- K980917 — ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
- K980989 — 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
- K981008 — SIMAL CERVICAL STABILIZATION SYSTEM
- K981373 — ALKPHASE-B ASSAY KIT
- K981457 — ALBP
- K981468 — ALBG
- K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
- K981626 — SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
- K973360 — MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
- K973544 — VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
- K973545 — VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
- K974123 — BRANEMARK SYSTEM DEC 600 DRILLING UNIT
- K974488 — AIRPREP SYSTEM - MODEL 9001
- K974596 — DIMERTEST LATEX ASSAY
- K980739 — HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
- K980746 — CEDIA DAU EDDP ASSAY
- K981043 — DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL
- K981061 — INTRAVASCULAR RETRIEVAL DEVICE
- K981099 — STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
- K981200 — IL TEST PLASMINOGEN
- K981206 — TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
- K981292 — QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
- K974245 — DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
- K974882 — DOWNSCAN LT
- K980687 — SONOS 5500 ULTRASOUND IMAGING SYSTEM
- K980690 — CABLE SCREW WITH INTEGRAL CRIMP
- K980710 — SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM
- K980713 — FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM
- K980717 — UROMED SLING KIT
- K980731 — ACCU-CHEK COMFORT CURVE TEST STRIPS
- K980781 — IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS
- K980788 — ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
- K980858 — MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
- K981037 — CLEAR (TM) SPECIAL NIT COMB
- K981211 — APR -T REVISION HIP STEM
- K981341 — STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
- K970968 — BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
- K973840 — FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
- K973929 — NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.