FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139321–139344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1987
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
K871685 · JXG
American V. Mueller
Neurology · 44d
Cleared Jun 12, 1987
CARDIO-MEGA SYSTEM
K871890 · DSI
Grandcor Medical Systems
Cardiovascular · 28d
Cleared Jun 12, 1987
QM300 C3 ANTIBODY PACK
K871939 · CZW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 12, 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · CZP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 12, 1987
EYEDENTITY EYEWEAR
K872062 · HQZ
Vitech Research C/O Johnsen, Manfredi...
Ophthalmic · 15d
Cleared Jun 12, 1987
K-GEL
K872128 · KMJ
Taro Pharmaceuticals, Inc.
General Hospital · 10d
Cleared Jun 11, 1987
ENDOCATER
K863393 · LQY
The Hygenic Corp.
Dental · 281d
Cleared Jun 11, 1987
QUIK-BRUSH
K870414 · EFW
Intl. Medication Systems, Ltd.
Dental · 128d
Cleared Jun 11, 1987
4-9295 BARBITURATES TEST MIX
K871174 · DKB
Supelco, Inc.
Toxicology · 79d
Cleared Jun 11, 1987
LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
K871304 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 71d
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