FDA 510(k) clearances — page 910
clearances on record, most recent first.
Clearances — page 910
90,901–91,000 of 176,637- 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
- K974141 — PLUS REUSABLE RESUSCITATOR
- K974571 — SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
- K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
- K980401 — FLEXIBLE FIBERSCOPES AND ACCESSORIES
- K980673 — SPYROSORB FOAM ISLAND WOUND DRESSING
- K980676 — SPIGAL NEEDLE
- K981091 — NEOCOLLOID, ORTHOPRINT
- K972595 — ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
- K973615 — SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
- K974513 — PINPOINT
- K974536 — PHOTODERM HR SYSTEM
- K974540 — SIS HERNIA REPAIR DEVICE
- K974830 — ULTRA BILI LIGHT
- K980125 — REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
- K980319 — DUREX ULTRA COMFORT
- K980563 — SKAR-KARE SHEET
- K980636 — FIBER OPTIC ENDOILLUMINATION PROBE
- K980665 — REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
- K980685 — MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
- K980750 — RADIOCAMERAS PATIENT POSITIONING SYSTEM
- K980794 — DUAL LOCK HIP STEM
- K980837 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
- K980841 — RCI FIXATION SCREWS
- K980842 — COPPER TONGUE SCRAPER
- K980861 — DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
- K980862 — TITANIUM SPINAL ROD SYSTEM
- K980866 — MEDI-DX 7000 CPT WITH AMREX ELECTRODES
- K980880 — SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)
- K980981 — OMEGA HA COATED TOTAL HIP SYSTEM
- K981045 — EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
- K981070 — 20-HOLE ADAPTATION PLATE
- K981156 — DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
- K981188 — ELECTROSURGICAL CAUTERY PROBES
- K981245 — ALKALINE PHOSPHATASE (ALKP)
- K981279 — TIBC
- K981404 — FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
- K981407 — OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
- K981423 — AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
- K981452 — OSTEONICS LONG ARM CONTAINMENT RING
- K981458 — KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
- K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM
- K980018 — CRISTOBAL
- K980292 — CATARACT LIQUEFRACTURE DEVICE
- K980295 — OPHTHAVISION IMAGING SYSTEM
- K980604 — SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
- K980625 — SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
- K980656 — PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
- K980658 — PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
- K980797 — PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
- K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM
- K981169 — RONDEX CPR ISO-SHIELD
- K970726 — VAPOCIDE
- K972114 — OLYMPUS SONOSURG SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.