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
50257–50280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2010
GSP NEONATALGALT KIT, MODEL 3303-001U
K100101 · KQP
Perkinelmer, Inc.
Chemistry · 149d
Cleared Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · DRX
Ambu A/S
Cardiovascular · 143d
Cleared Jun 11, 2010
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100429 · FRO
Laboratoires Urgo
General & Plastic Surgery · 115d
Cleared Jun 11, 2010
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100430 · FRO
Laboratoires Urgo
General & Plastic Surgery · 115d
Cleared Jun 11, 2010
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
K100480 · BTO
Vitaltec Corporation
Anesthesiology · 113d
Cleared Jun 11, 2010
G-FORCE PEEK SUTURE ANCHOR SYSTEM
K100630 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared Jun 11, 2010
FIBER ONE
K100746 · GEX
American Medical Systems
General & Plastic Surgery · 87d
Cleared Jun 11, 2010
PREVENA INCISION MANAGEMENT SYSTEM
K100821 · OMP
Kci USA, Inc.
General & Plastic Surgery · 80d
Cleared Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
K101075 · JJX
Roche Diagnostics Corp.
Chemistry · 53d
Cleared Jun 11, 2010
PATIENT MONITOR, MODEL PM50
K101127 · MWI
Contec Medical System Co., Ltd.
Cardiovascular · 50d
Cleared Jun 11, 2010
GENESIS DM MODEL: 6053000A1
K101242 · DRG
Honeywell Hommed, LLC
Cardiovascular · 39d
Cleared Jun 11, 2010
VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
K101274 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 36d
Cleared Jun 11, 2010
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE...
K101334 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 11, 2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
K101419 · DQK
St Jude Medical
Cardiovascular · 22d
Cleared Jun 10, 2010
VIBRO-TRAC
K092731 · JFB
Pneumex, Inc.
Physical Medicine · 279d
Cleared Jun 10, 2010
GUIDED GROWTH SYSTEM
K093442 · OBT
Orthofix, Inc.
Orthopedic · 217d
Cleared Jun 10, 2010
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP,...
K093679 · FZP
AtriCure, Inc.
General & Plastic Surgery · 195d
Cleared Jun 10, 2010
BLOOD PRESSURE METER, MODEL CH-4532
K093931 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 170d
Cleared Jun 10, 2010
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
K100137 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 142d
Cleared Jun 10, 2010
RETRIEVE IMPLANT CEMENT
K101044 · EMA
Parkell, Inc.
Dental · 57d
Cleared Jun 10, 2010
FLEXI-LITE
K101262 · CBF
Pressure-Tech, Inc.
Anesthesiology · 36d
Cleared Jun 09, 2010
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
K093297 · KHP
Epocal, Inc.
Chemistry · 231d
Cleared Jun 09, 2010
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
K093819 · NBW
Arkray Factory USA, Inc.
Chemistry · 177d
Cleared Jun 09, 2010
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
K100398 · NBW
Standard Diagnostics, Inc.
Chemistry · 113d