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
137497–137520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1988
BIO-COR EXT COLLAGEN CORNEAL SHIELD
K874225 · MOE
Bausch & Lomb, Inc.
Ophthalmic · 98d
Cleared Jan 22, 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418 · BTM
Life Support Products, Inc.
Anesthesiology · 86d
Cleared Jan 22, 1988
USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)
K874506 · JGJ
Technicon Instruments Corp.
Chemistry · 81d
Cleared Jan 22, 1988
ENVINET(TM)
K874551 · EFQ
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Jan 22, 1988
ENVISAN PAD
K874552 · KOZ
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Jan 22, 1988
DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
K874735 · GXY
Dantec Electronics, Inc.
Neurology · 65d
Cleared Jan 22, 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736 · IPF
Rich-Mar Corp.
Physical Medicine · 65d
Cleared Jan 22, 1988
DEY-PAK PURIFIED WATER, USP, STERILE
K875011 · CCQ
Dey Laboratories, Inc.
Anesthesiology · 49d
Cleared Jan 22, 1988
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
K875019 · HBF
Neurodynamics, Inc.
Neurology · 49d
Cleared Jan 22, 1988
DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP
K875024 · CCQ
Dey Laboratories, Inc.
Anesthesiology · 49d
Cleared Jan 22, 1988
RONGEUR (NEUROSURGICAL INSTRUMENTS)
K875043 · HAE
Solway, Inc.
Neurology · 51d
Cleared Jan 22, 1988
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
K875164 · DFH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 22, 1988
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · DEH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 22, 1988
DISPOSABLE SURGICAL FACE MASK
K875172 · FXX
Irema USA , Ltd.
General Hospital · 36d
Cleared Jan 22, 1988
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
K875194 · FXX
Welch Allyn, Inc.
General Hospital · 36d
Cleared Jan 22, 1988
TOTAL PROTEIN
K875222 · CEK
Catachem, Inc.
Chemistry · 31d
Cleared Jan 22, 1988
KIMBERLY-CLARK FULL COVERAGE HOOD
K875261 · FYF
Kimberly-Clark Corp.
General & Plastic Surgery · 32d
Cleared Jan 22, 1988
TMM MODEL 2500 CAPMONITOR
K875268 · CCK
Traverse Medical Monitors
Anesthesiology · 31d
Cleared Jan 22, 1988
BITEK(TM) BLOOD CULTURE SYSTEM
K875273 · JSG
Definitive Diagnostics, Inc.
Microbiology · 29d
Cleared Jan 22, 1988
SUCTION RETRACTOR
K875289 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 23d
Cleared Jan 22, 1988
SPINAL SURGERY FRAME
K875291 · BWN
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 23d
Cleared Jan 22, 1988
NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS
K875319 · GEN
I-Tech Industries, Inc.
General & Plastic Surgery · 24d
Cleared Jan 21, 1988
WAKO(TM) PRETEST 5A
K873366 · CDM
Wako Chemicals USA, Inc.
Chemistry · 153d
Cleared Jan 21, 1988
A-GENT TRIGLLYCERIDES GPO
K874187 · CDT
Abbott Laboratories
Chemistry · 99d