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
139537–139560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1987
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
K872156 · HWC
Concept, Inc.
Orthopedic · 47d
Cleared Jul 21, 1987
DIDECO-SHILEY WASTE COLLECTION BAG
K872158 · CAC
Shiley, Inc.
Anesthesiology · 47d
Cleared Jul 21, 1987
DIDECO-SHILEY BLOOD REINFUSION BAG
K872162 · CAC
Shiley, Inc.
Anesthesiology · 47d
Cleared Jul 21, 1987
ETHANOL CALIBRATOR
K872181 · DLJ
American Monitor Corp.
Toxicology · 43d
Cleared Jul 21, 1987
AMBULATORY EEG PLAYBACK
K872183 · GWQ
Cadwell Laboratories, Inc.
Neurology · 43d
Cleared Jul 21, 1987
CORD-ASSURE UMBILICAL BLOOD GAS KIT
K872244 · CBT
Lake Medical Products, Inc.
Anesthesiology · 40d
Cleared Jul 21, 1987
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · DSH
Medtronic Vascular
Cardiovascular · 40d
Cleared Jul 21, 1987
SIRECUST MODEL 960 AND 961 PATIENT MONITORING
K872249 · DRT
Medical Electronics Laboratories, Inc.
Cardiovascular · 39d
Cleared Jul 21, 1987
ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP
K872270 · HRX
Orthoconcept, Inc.
Orthopedic · 39d
Cleared Jul 21, 1987
TRAKEFIT TRACHEOSTOMY TUBE HOLDER
K872277 · CBH
Ackrad Laboratories
Anesthesiology · 36d
Cleared Jul 21, 1987
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 35d
Cleared Jul 21, 1987
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
K872349 · DLJ
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · DRT
Marquette Electronics, Inc.
Cardiovascular · 33d
Cleared Jul 21, 1987
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 29d
Cleared Jul 21, 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443 · DRT
Puritan Bennett Corp.
Cardiovascular · 28d
Cleared Jul 21, 1987
NOMAD (BASE UNIT/PORTABLE UNIT)
K872449 · BYJ
Minnesota Valley Engineering, Inc.
Anesthesiology · 28d
Cleared Jul 21, 1987
AN3500 WORTH DRAIN
K872457 · GBS
H.W. Andersen Products, Inc.
General & Plastic Surgery · 28d
Cleared Jul 21, 1987
AN3100 MULHOLLAND DRAIN
K872459 · GBS
H.W. Andersen Products, Inc.
General & Plastic Surgery · 28d
Cleared Jul 21, 1987
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET
K872461 · DLJ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET
K872462 · DLJ
Innotron of Oregon, Inc.
Toxicology · 29d
Cleared Jul 21, 1987
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET
K872463 · DLJ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS
K872511 · CHJ
Catachem, Inc.
Chemistry · 27d
Cleared Jul 21, 1987
1.1 COUPLERS AND 1.2 ADAPTERS
K872550 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared Jul 21, 1987
ANTI-DNP MICROASSAY
K872560 · DHN
Diamedix Corp.
Immunology · 22d