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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
79897–79920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared May 18, 2001
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
K011233 · CGA
Apex BioTechnology Corp.
Chemistry · 25d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Hardy Diagnostics
Microbiology · 11d
Cleared May 17, 2001
STEREOTACTIC FRAME BASED SYSTEM
K003486 · HAW
Stryker Instruments
Neurology · 185d
Cleared May 17, 2001
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K010101 · JWH
Kinamed, Inc.
Orthopedic · 126d
Cleared May 17, 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 119d
Cleared May 17, 2001
RADCALC, MODEL V.4.0
K010464 · IYE
Lifeline Software, Inc.
Radiology · 90d
Cleared May 17, 2001
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K010551 · NDF
Ebi, L.P.
Orthopedic · 80d
Cleared May 17, 2001
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
K010620 · GCJ
Onux Medical, Inc.
General & Plastic Surgery · 77d
Cleared May 17, 2001
CLASSIC CEM
K011064 · EMA
S & C Polymer GmbH
Dental · 41d
Cleared May 17, 2001
XSE
K011167 · KLE
3M Company
Dental · 31d
Cleared May 17, 2001
SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE,...
K011198 · LZA
Maxxim Medical, Inc.
General Hospital · 28d
Cleared May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · LDJ
Syva Co., Dade Behring, Inc.
Toxicology · 17d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · DIP
Syva Co.
Toxicology · 15d
Cleared May 16, 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · DZE
Lifecore Biomedical, Inc.
Dental · 315d
Cleared May 16, 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084 · DQX
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · DQO
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
K003609 · NEO
Osteometer Biotech A/S
Chemistry · 175d
Cleared May 16, 2001
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
K003707 · MWJ
Cardionet
Cardiovascular · 166d
Cleared May 16, 2001
MODIFICATION TO MALE TO MALE LUER ADAPTER
K003712 · KOC
Molded Products, Inc.
Gastroenterology & Urology · 166d
Cleared May 16, 2001
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
K003732 · DXN
Braun GmbH
Cardiovascular · 163d
Cleared May 16, 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F),...
K003880 · DQY
Concentric Medical, Inc.
Cardiovascular · 152d
Cleared May 16, 2001
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
K010448 · FBK
Horizons Intl. Corp.
Gastroenterology & Urology · 90d
Cleared May 16, 2001
TETHER ACFS
K010466 · KWQ
Theken Surgical,Llc
Orthopedic · 89d