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
42121–42144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2013
SHEATHES STERILE ULTRASOUND GEL
K130041 · MUI
Sheathing Technologies, Inc.
Radiology · 29d
Cleared Feb 05, 2013
A-GRIX TE RESORABLE BONE VOID FILLER
K121453 · MQV
Ag Digital Technology Corp.
Orthopedic · 265d
Cleared Feb 05, 2013
AUGMENT AND SCREW, PSA TYPE
K122183 · JWH
United Orthopedic Corp.
Orthopedic · 197d
Cleared Feb 05, 2013
DIGITAL THERMOMTER
K122520 · FLL
Taidoc Technology Corporation
General Hospital · 172d
Cleared Feb 05, 2013
RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
K122781 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 147d
Cleared Feb 05, 2013
PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
K122805 · MBI
Parcus Medical, LLC
Orthopedic · 145d
Cleared Feb 05, 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I...
K123050 · LCX
Nantong Biotechnology Co., Ltd.
Chemistry · 130d
Cleared Feb 05, 2013
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
K123114 · GDW
Ethicon, Inc.
General & Plastic Surgery · 125d
Cleared Feb 05, 2013
PASS LP SPINAL SYSTEM
K123138 · OSH
Medicrea International
Orthopedic · 123d
Cleared Feb 05, 2013
VISCOSTAT CLEAR
K123215 · MVL
Ultradent Products, Inc.
Dental · 113d
Cleared Feb 05, 2013
CARDEASCREEN
K123217 · DPS
Cardea Associates, Inc.
Cardiovascular · 113d
Cleared Feb 05, 2013
GIRAFFE AND PANDA WARMERS
K123309 · FMT
Ohmeda Medical
General Hospital · 104d
Cleared Feb 05, 2013
PROFEMUR Z CLASSIC STEMS
K123434 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Feb 05, 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · DSY
LeMaitre Vascular, Inc.
Cardiovascular · 35d
Cleared Feb 04, 2013
CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
K120804 · PBY
Cianna Medical
General & Plastic Surgery · 325d
Cleared Feb 04, 2013
WRIST PULSE OXIMETER
K122046 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 207d
Cleared Feb 04, 2013
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
K123170 · KNY
Olympus Surgical Technologies America
Gastroenterology & Urology · 118d
Cleared Feb 04, 2013
AUTOMATED ENDOSCOPE LEAK TESTER
K123704 · PCV
Olympus Medical Systems Corp.
Gastroenterology & Urology · 63d
Cleared Feb 01, 2013
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY...
K111275 · FRN
Smiths Medical Asd, Inc.
General Hospital · 637d
Cleared Feb 01, 2013
DEKA SMARTXIDE AND DELIVERY ACCESSORIES
K113504 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 431d
Cleared Feb 01, 2013
DIOLASE 10S
K121327 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 275d
Cleared Feb 01, 2013
PLANMED VERITY
K121418 · JAK
Planmed OY
Radiology · 266d
Cleared Feb 01, 2013
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
K121456 · KQO
Arkray, Inc.
Chemistry · 261d
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · CIG
Abbott Laboratories
Chemistry · 210d