FDA 510(k) clearances — page 954
clearances on record, most recent first.
Clearances — page 954
95,301–95,400 of 176,637- K971445 — ALB OR ALBUMIN
- K963289 — INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
- K964187 — FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
- K964236 — (MODIFIED) ETEST PACKAGE INSERT
- K970174 — FREEPIX/PIXPACS DICOM/HTTP GATEWAY
- K970210 — AMIKACIN
- K970379 — CHANNEL BALLOON CATHETER
- K970473 — ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
- K970789 — SAFE-CONNECT VIAL DISPENSING SPIKE
- K971266 — SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518
- K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
- K960951 — PERMOBIL CHAIRMAN L/CS 8
- K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
- K964208 — MD-1A GALVANIC UNIT
- K965199 — TUNA 5 CATHETER
- K965205 — TEFGEN - LS
- K970353 — AURA TEK FDP
- K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115)
- K970423 — INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
- K970442 — TARGET VITAL-PORT VASCULAR ACCESS SYSTEM
- K970447 — IMPLEX BIPOLAR HIP SYSTEM
- K970448 — PCM 2000; ISOLAIR APR MODEL 2735
- K970493 — HYFRECATOR 2000
- K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
- K970500 — 3M SUSTEL DENTAL SYSTEM
- K970501 — PEGGED ACETABULAR COMPONENT
- K970503 — DEPUY ACE TROCHANTERIC SIDE PLATE
- K970549 — TITANIUM ALLOY BONE SCREWS
- K970743 — BCW POWER ADVANTAGE WHEELCHAIR
- K970841 — IMTEC/TITANIUM MESH
- K970963 — TARGIS ALLOY #7
- K964642 — MEDRAD DISPOSABLE SYRINGES
- K964695 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
- K970204 — BK-A; BK-B; BK-IS SEALING CAP
- K970345 — ALIGNMENT INSTRUMENT
- K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
- K970429 — BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
- K955026 — AS/3 NMT MODULE
- K963381 — QUICKIE P300 SERIES
- K963382 — QUICKIE P100 SERIES
- K963385 — QUICKIE POWER WHEELCHAIRS P200 SERIES
- K963601 — MODEL 1920 WASTE GAS SCAVENGER
- K963916 — IMMULITE CANNABINOIDS
- K964119 — WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
- K964400 — ALPHATEC EXTERNAL FIXATION SYSTEM
- K970623 — IMMERGE IMAGE CORRELATION
- K971128 — CAP-35B III/CINE 275
- K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
- K971142 — ADVENTURER
- K941514 — VENTANA ANTI-S100 PRIMARY ANTIBODY
- K953982 — SIMPLEX TENS
- K954204 — DRAGER INCUBATOR 8000 IC
- K962930 — SPACELABS MEDICAL ECG ANALYSIS SYSTEM
- K964715 — PARAMAX SALICYLATE REAGENT
- K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
- K964766 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
- K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZER
- K970303 — SATURNE MULTILEAF COLLIMATOR
- K970317 — MODIFIED E-PACK PROCEDURE KIT
- K970334 — NATURE'S CRADLE
- K970380 — F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM
- K970593 — UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
- K970607 — UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
- K970820 — ETEST SPARFLOXACIN
- K971122 — ACCULINE PREGNANCY TEST
- K960764 — SAFE-CATH
- K962882 — SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
- K962936 — IMMULITE TOXOPLASMA QUANTITATIVE IGG
- K963886 — EVS
- K963989 — P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
- K963991 — FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
- K963996 — (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400
- K965183 — VANTAGE PERIPHERAL DILATATION CATHETER
- K970288 — CLINICAL DIAGNOSTIC SOFTWARE
- K970291 — ACCESSORIES TO THE STEREOTACTIC BODY FRAM
- K970299 — JUPITER PTA CATHETERS (VARIOUS)
- K970392 — CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
- K970519 — UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
- K970574 — ACUPUNCTURE NEEDLES
- K970697 — OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
- K970832 — PYR SWAB
- K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY
- K962087 — SERVOTRONIC EC100 SYSTEM
- K963223 — EZ-CIRC
- K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
- K964288 — CALL-RAD PC TELERADIOLOGY
- K964377 — THERMAL REGULATION SYSTEM BLANKET
- K964393 — CHASE RETROGRADE CARDIOPLEGIA CANNULA
- K964756 — PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
- K964956 — E-Z SPACER MASK (SMALL)
- K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
- K970033 — MONARCH IOL DELIVERY SYSTEM
- K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING
- K970292 — IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
- K970341 — MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
- K970631 — PUNCTUAL OCCLUDER
- K970930 — BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
- K970949 — SMITH & NEPHEW MIS INSTRUMENTS
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K971014 — LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
Data sourced from openFDA. This site is unofficial and independent of the FDA.