FDA 510(k) clearances — page 906
clearances on record, most recent first.
Clearances — page 906
90,501–90,600 of 175,890- K980660 — BIOGOLD PLUS DENTAL ALLOY
- K980772 — HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
- K980944 — SYNTHES SCHUHLI IMPLANT SYSTEM
- K981098 — STRATUS CS CARDIAC TROPONIN I TESTPAK
- K981102 — STRATUS CS MYOGLOBIN (MYO) TESTPAK
- K981178 — THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
- K981289 — N-ASSAY L T-BIL
- K972911 — AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
- K972793 — PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
- K973556 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
- K973874 — ACL CLIP-IN PLATE
- K973986 — MECTEST
- K974840 — ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
- K980276 — STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM
- K980279 — SONY DXC-LS1 COLOR VIDEO CAMERA
- K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER
- K980294 — ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K980299 — APEX OXIMETER
- K980322 — ACCENT 16, ACCENT 22
- K980357 — KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
- K980391 — SERAQUEST ANTI-DSDNA
- K980402 — CAPINTEC MODEL 292 ELECTROMETER
- K980557 — SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
- K980614 — ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
- K981123 — UREA
- K981222 — DIRECT BILIRUBIN (DBIL)
- K981281 — ELECSYS CALCHECK FERRITIN
- K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
- K965212 — STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
- K974424 — COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
- K974747 — CS/3 ARRHYTHMIA WORKSTATION
- K980059 — SERAQUEST MUMPS IGG
- K980227 — MANAN GALACTOGRAPHY KIT
- K980376 — THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY
- K980516 — REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
- K980759 — DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
- K981164 — POWDER FREE CHLORINATED GLOVES-(TEXTURED)
- K981221 — ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
- K981225 — ASPARTATE AMINOTRANSFERASE (AST)
- K981278 — ELECSYS CALCHECK CA 125II
- K974598 — MICROKERATOME OR THE MATE
- K980634 — FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
- K980795 — UROLOGICAL BALLOON DILATATION CATHETER
- K980851 — GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
- K981142 — MAICO MA53
- K981229 — MANAN MANTA CATHETER FIXATION DISK
- K981258 — MANAN MALECOT BASKET DRAINAGE CATHETER
- K981318 — DUAL LUER LOCK CAP
- K964488 — DETACHABLE SILICONE BALLOON (DSB)
- K965071 — DETACHABLE SLICONE BALLOON (DSB)
- K972548 — SLT CL MD CONTACT LASER SYSTEM
- K973896 — OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
- K974057 — DENTEK LD 15 LASERSYSTEM
- K974371 — CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
- K974382 — ACKERMANN SURGICAL INSTRUMENTS
- K974602 — OPTICAL TRACKING SYSTEM (OTS)
- K974842 — IMMULITE 2000 3RD GENERATION PSA
- K980033 — FERNO HEALTHCARE RECLINE-A-BATH 2
- K980214 — EXCEL NEURO WORKS
- K980245 — NITOM LOCKING FACEBOW
- K980361 — DERMABLATE ER: YAG LASER SYSTEM
- K980465 — OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
- K980667 — INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
- K980757 — ILAB 600 CLINICAL CHEMISTRY SYSTEM
- K980770 — HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
- K980783 — SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
- K980853 — CEDIA DAU MULTI-DRUG CALIBRATORS
- K980855 — IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
- K980875 — IL TEST PROTEIN C
- K980898 — FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER
- K981035 — PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
- K981039 — POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
- K981090 — LASERLITE DIODE SURGICAL LASER
- K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT
- K981339 — QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
- K971407 — JTECH COMMANDER AND ALGOMETER
- K971504 — HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
- K973639 — ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
- K980165 — INFUTEST 2000 INFUSION DEVICE ANALYZER
- K980657 — AHMED GLAUCOMA VALVE, MODEL S3
- K980864 — POWER COINS GLOW IN THE DARK LIGATURES
- K961486 — IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
- K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
- K974315 — VIDAR VXR LS LASER FILM DIGITIZER
- K980199 — SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
- K980204 — DUREX LATEX CONDOMS
- K980296 — OLDELFT DIGIDELCA
- K980581 — PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
- K980587 — IV DECANTER-FLEXIBLE
- K972800 — PTA BALLOON CATHETER
- K973775 — HARPOON SUTURE ANCHORS
- K974341 — MITEK BTB ABSORBABLE (PLA) CROSS PIN
- K974408 — PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
- K974776 — MDA D-DIMER
- K980164 — STERICHEK PERACETIC ACID REAGENT STRIPS
- K980239 — PARTNERSHIP CALCAR FEMORAL COMPONENTS
- K980305 — AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
- K980324 — MICROSTREAM FILLERLINE OR/EMS
- K980325 — MICROSTREAM NASAL CANNULA FILTERLINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.