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
50185–50208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2010
NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX,...
K101080 · GEI
Egon Faulhaber Surgical Instruments...
General & Plastic Surgery · 63d
Cleared Jun 21, 2010
OPUS SPEEDSCREW SYSTEM
K101448 · MBI
Arthrocare Corp.
Orthopedic · 28d
Cleared Jun 18, 2010
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE...
K091786 · DXG
Pulsion Medical Systems AG
Cardiovascular · 366d
Cleared Jun 18, 2010
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
K092052 · NBW
Bionime Corporation
Chemistry · 346d
Cleared Jun 18, 2010
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701,...
K092938 · NZW
App Pharmaceuticals, LLC
General Hospital · 267d
Cleared Jun 18, 2010
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
K093109 · FMI
Novo Nordisk, Inc.
General Hospital · 260d
Cleared Jun 18, 2010
DRYODINE CADEXOMER-IODINE GEL
K093320 · FRO
Collegium Pharmaceutical Incorporated
General & Plastic Surgery · 238d
Cleared Jun 18, 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 235d
Cleared Jun 18, 2010
LASSO NAV CATHETER
K093376 · DRF
Biosense Webster, Inc.
Cardiovascular · 232d
Cleared Jun 18, 2010
CARTO XP EP NAVIGATION SYSTEM, VERSION 10
K093566 · DQK
Biosense Webster, Inc.
Cardiovascular · 212d
Cleared Jun 18, 2010
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2...
K093623 · CIG
Instrumentation Laboratory CO
Chemistry · 207d
Cleared Jun 18, 2010
BF-NAVI
K093810 · JAK
Kgt, Inc.
Radiology · 189d
Cleared Jun 18, 2010
MULTIFUNCTIONAL LINEAR PEN
K100501 · OCL
AtriCure, Inc.
Cardiovascular · 116d
Cleared Jun 18, 2010
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH,...
K100638 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 105d
Cleared Jun 18, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · KWP
Alphatec Spine, Inc.
Orthopedic · 100d
Cleared Jun 18, 2010
PUMA MODEL VERSION 1.0
K100801 · IYE
Prowess, Inc.
Radiology · 88d
Cleared Jun 18, 2010
MOTIVATION KNEE SYSTEM
K100900 · JWH
Encore Medical, L.P.
Orthopedic · 79d
Cleared Jun 18, 2010
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL...
K101111 · GEI
Barrx Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jun 18, 2010
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
K101115 · DPS
Mortara Instrument, Inc.
Cardiovascular · 58d
Cleared Jun 18, 2010
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
K101440 · OTN
Generic Medical Devices, Inc.
Gastroenterology & Urology · 25d
Cleared Jun 18, 2010
INTELLIVUE PATIENT MONITOR
K101449 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 25d
Cleared Jun 18, 2010
COMPRESS ANTI-ROTATION SPINDLES
K101475 · KWA
Biomet Manufacturing Corp
Orthopedic · 21d
Cleared Jun 17, 2010
O-ARM IMAGING SYSTEM
K092564 · OXO
Medtronic Navigation, Inc. (Littleton)
Radiology · 301d
Cleared Jun 17, 2010
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND...
K093395 · IYN
Olympus Medical Systems Corporation
Radiology · 230d