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
48145–48168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2011
VACPLUS SUCTION UNIT
K103535 · JCX
Apex Medical Corp.
General & Plastic Surgery · 85d
Cleared Feb 24, 2011
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K110012 · OMN
Meridian Bioscience, Inc.
Microbiology · 52d
Cleared Feb 24, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
K110080 · GEX
Biolitec, Inc.
General & Plastic Surgery · 44d
Cleared Feb 24, 2011
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH
K110193 · DXC
St. Jude Medical Systems AB
Cardiovascular · 31d
Cleared Feb 23, 2011
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL...
K100464 · NSF
Wako Chemicals USA, Inc.
Immunology · 370d
Cleared Feb 23, 2011
ASTRA TECH IMPLANT SYSTEM
K101732 · DZE
Astra Tech AB
Dental · 247d
Cleared Feb 23, 2011
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
K102125 · JWH
Biomet, Inc.
Orthopedic · 209d
Cleared Feb 23, 2011
INDISCAL DIGITAL MANOMETER
K102192 · FMF
Baylis Medical Co., Inc.
General Hospital · 203d
Cleared Feb 23, 2011
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
K102769 · OAT
Jjgc Industria E Comercio DE...
Dental · 152d
Cleared CT Feb 23, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
K102939 · DXN
Andon Health Co, Ltd.
Cardiovascular · 142d
Cleared Feb 23, 2011
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · FYA
Microtek Medical, Inc.
General Hospital · 140d
Cleared Feb 23, 2011
DYNAFLEX
K103076 · LRK
Dyna Flex
Dental · 128d
Cleared Feb 23, 2011
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP...
K103128 · ETN
Cadwell Lab, Inc.
Ear, Nose, Throat · 121d
Cleared Feb 23, 2011
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
K103264 · FEB
Olympus Medical Systems Corporation
General Hospital · 111d
Cleared Feb 23, 2011
EBONY PTA .035 PERIPHERAL DILATATION CATHETER
K103354 · LIT
Natec Medical , Ltd.
Cardiovascular · 99d
Cleared Feb 23, 2011
ASCOM CLINICALCONNEX CARDIOMAX
K103634 · MSX
Ascom (Us), Inc.
Cardiovascular · 72d
Cleared Feb 23, 2011
V-GO INSULIN DELIVERY SYSTEM
K103825 · LZG
Valeritas, Inc.
General Hospital · 55d
Cleared Feb 23, 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
K110228 · HQB
Nidek Incorporated
Ophthalmic · 28d
Cleared Feb 22, 2011
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
K101793 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 239d
Cleared Feb 22, 2011
ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
K102270 · DQA
Envitec-Wismar GmbH
Anesthesiology · 196d
Cleared Feb 22, 2011
ALACER SURGICAL SCAFFOLD
K103445 · FTL
Alacer Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Feb 22, 2011
ML24000 UVA-1 PHOTOTHERAPY UNIT
K103708 · FTC
The Daavlin Distributing Company
General & Plastic Surgery · 64d
Cleared Feb 18, 2011
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
K101233 · MEG
Rexam Pharma
General Hospital · 291d
Cleared Feb 18, 2011
FASTPACK TESTO IMMUNOASSAY
K101388 · CDZ
Qualigen, Inc.
Chemistry · 277d