Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47785–47808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2011
XPERT C. DIFFICLE/EPI ASSAY
K110203 · OMN
Cepheid
Microbiology · 73d
Cleared Apr 07, 2011
ACCULIF CAGE
K110270 · MAX
Coalign Innovations, Inc.
Orthopedic · 66d
Cleared Apr 07, 2011
MOUNTAINEER OCT SPINAL SYSTEM
K110353 · KWP
Depuy Spine, Inc.
Orthopedic · 59d
Cleared Apr 07, 2011
4D SONO-SCAN 1.0
K110595 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 36d
Cleared Apr 07, 2011
XVAC
K110782 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 17d
Cleared Apr 06, 2011
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7...
K100375 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 418d
Cleared Apr 06, 2011
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
K100669 · GEI
Us Medical Innovations, LLC
General & Plastic Surgery · 393d
Cleared Apr 06, 2011
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
K102225 · DJZ
Alcopro, Inc.
Toxicology · 240d
Cleared Apr 06, 2011
RESUSCI FLOW
K102542 · BTL
Atom Medical Corporation
Anesthesiology · 215d
Cleared Apr 06, 2011
MULTIPLE BIOPSY SYSTEM
K103326 · FCK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 145d
Cleared Apr 06, 2011
HAIRMAX LASERCOMB
K103368 · OAP
Lexington International, LLC
General & Plastic Surgery · 140d
Cleared Apr 06, 2011
DISPOSABLE BLLOD COLLECTION NEEDLE
K103587 · FMI
Weihai Hongyu Medical Devices Co., Ltd.
General Hospital · 120d
Cleared Apr 06, 2011
ISA CO2, ISA AX+, ISA OR+
K103604 · CCK
Phasein AB
Anesthesiology · 118d
Cleared Apr 06, 2011
VELA XL
K103654 · GEX
Starmedtec GmbH
General & Plastic Surgery · 112d
Cleared Apr 06, 2011
MICROLIFE DIGITAL UNDERARM THERMOMETER
K103680 · FLL
Microlife Intellectual Property GmbH
General Hospital · 110d
Cleared Apr 06, 2011
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260 · OAS
Qr S.R.L.
Radiology · 68d
Cleared Apr 06, 2011
TEMPOROMANIBULAR COIL 15
K110373 · MOS
Esaote, S.P.A.
Radiology · 57d
Cleared Apr 06, 2011
SYNGO MBF
K110494 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Apr 06, 2011
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K110499 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 43d
Cleared Apr 06, 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 20d
Cleared CT Apr 05, 2011
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K100767 · MOL
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 383d
Cleared Apr 05, 2011
AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
K101057 · GEI
Salient Surgical Technologies
General & Plastic Surgery · 355d
Cleared Apr 05, 2011
HEMOSIL LA POSITIVE CONTROL
K102552 · GGC
Instrumentation Laboratory CO
Hematology · 210d
Cleared Apr 05, 2011
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · MNT
Respironics, Inc.
Anesthesiology · 180d