FDA 510(k) clearances — page 1190
clearances on record, most recent first.
Clearances — page 1190
118,901–119,000 of 176,637- K921211 — NOW PREGNANCY TEST KIT
- K921212 — MIRCO ELISA HPL TEST KIT
- K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
- K914190 — AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
- K914836 — OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
- K914991 — VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS
- K915446 — STRETCH WRAP
- K920236 — CHOLANGIOGRAM CATHETER KIT
- K920263 — MANUAL SURGICAL INSTRUMENTS
- K920547 — ULTRA-THIN
- K920643 — LAPAROSCOPIC SUCTION/IRRIGATION PROBE
- K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER
- K920769 — KONICA LI 10 AND 10A LASER IMAGER
- K921029 — DOBBHOFF BIPOLAR ADAPTER
- K921091 — CHOLANGIOLAPCATH(TM)
- K921282 — MAXAQUIN
- K921472 — M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)
- K921580 — BRINK PRE-MAXILLARY IMPLANT
- K921581 — CHIN WAFER
- K921582 — FLOWERS MEDIAL MALAR IMPLANT
- K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
- K913688 — BUD MAXILLOFACIAL IMPLANT SYSTEM
- K914152 — SIDESTREAM DRUG NEBULIZER
- K914615 — BTP(TM) CENTRALINE(TM) SUIT
- K915119 — SCALPEL BLADE REMOVER (BLADEGARD)
- K915507 — E-Z GOLD TOOTH FILLING MATERIAL
- K920102 — THE SELBY SYSTEM
- K920922 — GDC 3367
- K921117 — MINIDAM
- K921245 — THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
- K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT
- K921626 — TELETOM(R)
- K911202 — ATRAUMATIC STANDARD SPROTTE NEEDLE
- K911233 — CHAGAS' IGG ELISA TEST
- K912391 — RUBALEX, MODIFICATION
- K915210 — ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
- K915479 — CAPTIA CMV-TA
- K915896 — MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI
- K920515 — INSERTION
- K920710 — AIR MEDICA III
- K921351 — JACE MODEL PM-410 HAND CPM DEVICE
- K921554 — AMPHETAMINES EIA TEST
- K921647 — REGAL MOTORIZIED 3 WHEELED VEHICLE
- K921648 — BRUNO ELECTRA-RIDE STAIR-WAY ELEVATOR SYSTEM
- K921752 — AMBULATOR
- K920499 — SANI-TIP
- K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE
- K913342 — AUTOSTAT(TM) ANTI-DSNA
- K914205 — PFF-1
- K914256 — YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
- K914620 — HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION
- K914856 — VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
- K920088 — CAMINO VENTRICULAR NEEDLE
- K920147 — THROMBIN CLOTTING TIME REAGENT
- K920169 — SUNGLASSES
- K920211 — SUN/SPORTGLASSES
- K920213 — MITEK ANCHOR, MITEK ANCHOR II
- K921269 — KODAK X-OMAT MODEL 180 LP PROCESSOR
- K913117 — ZB-860PA MULTIPARAMETER TRANSMITTER
- K913731 — ENZYGNOST(R) TOXOPLASMOSIS/IGG
- K914362 — TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS
- K914804 — RADIUS OSTEOTOMY PLATES
- K915175 — REDDICK RETRACTOR
- K915502 — MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES
- K915675 — ELECTRODE, ION SPECIFIC
- K915729 — AUQASOOTHE/AQUA MED
- K920179 — ZIPPIE P500
- K920378 — PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
- K920402 — ROCHE COBAS MIRA PLUS
- K920422 — B-D INTERLINK SYRINGE CANNULA
- K920483 — 10% PHOSPHORIC ACID ETCHING GEL
- K920485 — PUPLDENT ETCH N PREP
- K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
- K920589 — ANGLED DELIVERY DEVICE
- K920642 — MICRO-COLL COLLAGEN DERMAL WOUND SPRAY
- K920759 — CRITSPIN MICRO-HEMATOCRIT
- K920934 — HALOCATH LASER CATHETERS
- K921005 — AUTOLOADER
- K921069 — FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
- K921089 — LYPHOCHEK(R) FRUCTOSAMINE CONTROL
- K921095 — PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT
- K921206 — HCG CONTROL
- K921210 — SURGICAL INSTRUMENT STAND
- K921455 — ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
- K921467 — DRAKE & DRAKE/200 DL
- K921636 — VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
- K921768 — HAZEL II
- K921806 — VACUTAINER(R) BRAND SST(R) AND CAT TUBES
- K921817 — RIFTON MOR219 19 & RIFTON MOR225 25
- K921829 — RIONET HEARING AID HB-52S
- K902977 — K3 COMPUTER SYSTEMS
- K913910 — ENZYGNOST(R) ANTI-CMV IGG
- K914178 — CORRECTED-V.P.S.
- K914367 — ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
- K914624 — PH METER, MODIFICATION
- K914803 — SCHWABE RADIUS PLATES
- K914904 — THERAPEUTIC STIMULATOR 2100 (TS-2100)
- K915358 — PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
- K920095 — MRT-50 MULTIVIEW COIL
- K920103 — EPISCOPE, MODEL 47300
Data sourced from openFDA. This site is unofficial and independent of the FDA.