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
139921–139944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1987
ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT
K871308 · JHI
Allelix, Inc.
Chemistry · 71d
Cleared Jun 11, 1987
ACCULATOR 287EP
K871396 · GZJ
Accu Science Corp.
Neurology · 65d
Cleared Jun 11, 1987
VINYL POLYSILOXANE IMPRESSION SYSTEM
K871409 · ELW
Crown Delta Corp.
Dental · 64d
Cleared Jun 11, 1987
PHENYTOIN FPIA CALIBRATORS
K871423 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Jun 11, 1987
MICROCHECK LH OVULATION TEST
K871602 · CEP
Syntron Bioresearch, Inc.
Chemistry · 48d
Cleared Jun 11, 1987
TDXR REA(TM) ETHANOL
K871645 · DIC
Abbott Laboratories
Chemistry · 44d
Cleared Jun 11, 1987
ULTRA MAXITHINS PADS
K871716 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 38d
Cleared Jun 11, 1987
SUMMIT OPTICS POST-MYDRIATIC SPECTACLES
K871800 · HQY
Summit Optics, Inc.
Ophthalmic · 34d
Cleared Jun 11, 1987
SERIES TEN THOUSAND OCUTOME
K871871 · HQE
CooperVision, Inc.
Ophthalmic · 29d
Cleared Jun 11, 1987
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
K871973 · JJG
Instrumentation Laboratory CO
Chemistry · 20d
Cleared Jun 11, 1987
GAMMA GLUTAMYLTRANSFERASE REAGENT
K871979 · JPZ
Intersect Systems, Inc.
Chemistry · 20d
Cleared Jun 11, 1987
MULTICHEM LDH-L REAGENT
K872010 · CFJ
Simmler, Inc.
Chemistry · 16d
Cleared Jun 10, 1987
DS-II DIGITAL SONOGRAPHY SYSTEM
K864278 · DQD
Intl. Acoustics, Inc.
Cardiovascular · 223d
Cleared Jun 10, 1987
AMEDA AMECARE(R) NEONATAL INCUBATOR
K870222 · FMZ
Hollister, Inc.
General Hospital · 140d
Cleared Jun 10, 1987
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223 · FMZ
Hollister, Inc.
General Hospital · 140d
Cleared Jun 10, 1987
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · JTL
Oxoid U.S.A., Inc.
Microbiology · 93d
Cleared Jun 10, 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K871192 · LJT
Norfolk Medical Products, Inc.
General Hospital · 78d
Cleared Jun 10, 1987
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K871268 · HLI
G. Rodenstock Instrumente GmbH
Ophthalmic · 71d
Cleared Jun 10, 1987
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE
K871282 · FFT
Synectics-Dantec
Gastroenterology & Urology · 71d
Cleared Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
K871318 · JCA
Helena Laboratories
Hematology · 68d
Cleared Jun 10, 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · KNX
Coloplast A/S
Gastroenterology & Urology · 47d
Cleared Jun 10, 1987
CONVEEN(R) LEG-BAG (600 ML)
K871643 · KNX
Coloplast A/S
Gastroenterology & Urology · 44d
Cleared Jun 10, 1987
URETERAL STENT
K871667 · FAD
Penn Medical Devices, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 10, 1987
BIODAN TYPE COMET ELECTRODE
K871668 · DRX
National Medical Technology
Cardiovascular · 43d