FDA 510(k) clearances — page 1485
clearances on record, most recent first.
Clearances — page 1485
148,401–148,500 of 175,890- K844947 — EMIT ANCILLARY REAGENTS
- K844950 — EMIT AMITRIPTYLINE ASSAY
- K844951 — EMIT IMIPRAMINE ASSAY
- K844952 — EMIT NORTRIPTYLINE ASSAY
- K844953 — EMIT DESIPRAMINE ASSAY
- K850634 — SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
- K850789 — FLUTED SUCTION MENISCAL CUTTER
- K851177 — UNIVERSAL POWER FLEX
- K851256 — MOBIE SCOOTER
- K851257 — CRS ULTRALITE PREMIER
- K851374 — AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
- K851414 — SEGMENTAL SPINAL RODS
- K851681 — SAFESTRETCH INCONTINENCE SYSTEM
- K851919 — SUPRACONDYLAR BONE PLATE
- K851938 — OMNIMED SURGICAL GOWN
- K852201 — ECHOCLONAL HCG IRMA
- K852274 — ANSWER
- K852420 — BTM TOTAL HIP SYSTEM
- K852530 — WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
- K852531 — NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410
- K852555 — SPLINTREX
- K852560 — PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG
- K852561 — PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG
- K852562 — PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG
- K852563 — PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG
- K844809 — CONTINUOUS VENTILATOR
- K851266 — QRI-FLOW URINE FLOW MEASURING DEVICE
- K851370 — INTERFACE TRANSFUSION BLOOD FILTER #35
- K851441 — TACTICON 1600
- K851506 — SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
- K851628 — RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
- K851678 — OSTOMY BAGS URETHEROSTOMY
- K851679 — OSTOMY BAGS COLOSTOMY
- K851680 — OSTOMY BAGS ILEOSTOMY
- K852057 — ASCON SURGICAL INSTRUMENTS
- K852087 — CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
- K852243 — KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS
- K852245 — STILLE BONE CUTTING RORCEPS 10 1/4 IN SS 420 & 416
- K852252 — 870 SURGICAL SYS CONTROL PULSE MODIFICATION
- K852258 — SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER
- K852263 — PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
- K852277 — CATAPRESS TOURNIGUET
- K852330 — RETRACTOR, SURGICAL
- K852348 — PHILIPS SOLARIUM HP 3134
- K852426 — MANAN TROCAR STYLE BIOPSY NEEDLE
- K852427 — MANAN SPINAL NEEDLE
- K852428 — MANAN EPIDURAL NEEDLE
- K852433 — INFUSAFE 205 CATOLOG NO. 205.000
- K852488 — CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
- K844252 — MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
- K845036 — TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
- K850635 — ANSELL NO POWDER SURGEON'S GLOVES
- K850827 — GUIDE, WIRE, ANGIOGRAPHIC
- K850828 — WIRE, GUIDE - MODIFICATION
- K850829 — WIRE, GUIDE, CATHETER
- K850931 — ALBUMIN
- K851044 — CARDIOSTAT 3 RECORDER
- K851400 — SIRECUST 420 PATIENT DIALOG MONITOR
- K851626 — SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
- K851633 — CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL
- K852143 — HALL IRRIGATION SYSTEM
- K852154 — ACKRAD SIALOGRAPHY CATHETER
- K852202 — STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
- K852257 — SURE-COUNT 15 COUNT NEEDLE COUNTER
- K844894 — PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES
- K850727 — BHCG-ROCHE EIA
- K850851 — G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S
- K850907 — CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
- K850932 — CREATININE
- K850933 — URIC ACID
- K850934 — PHOSPHORUS
- K850936 — TOTAL PROTEINS
- K850938 — CHOLESTEROL
- K851376 — VENOUS RESERVOIR BAG BMR-1600
- K851401 — VENUOS RESERVOIR BAG BMR-1900
- K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN)
- K851808 — ELECTROLYTE ANALYZER
- K851950 — TANDEM E PAP
- K851990 — INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
- K852002 — CA BUFFER CA DYE
- K852005 — MG REAGENT
- K852066 — PREGNANCY CARD TEST
- K852158 — BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA
- K852262 — ASSIST CLINICAL CHEMISTRY ANALYZER
- K852291 — TIPSEP DIGOXIN RIA
- K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
- K852318 — COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
- K852319 — COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
- K844895 — OMS SILICONE OIL INJECTOR
- K850504 — COROMETRICS 500 INFANT MONITOR
- K851057 — LASERFLO BLOOD PERFUSION MONITOR 403
- K851152 — MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
- K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER
- K851652 — PAPILLOTOME
- K851682 — SAFESEAL REUSABLE URINAL SYSTEM
- K851840 — STOMAHESIVE SKIN BARRIER STERILE
- K852049 — MEDICAL TOILET SEAT
- K852209 — DEVO/MC29 OXYGEN CONCENTRATOR MC29D
- K852298 — TENS-AID STERILE ELECTRODES FOR POST-OP TENS
- K852308 — ST-460 SPIRO ANALYZER SPIROMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.