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
152353–152376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1984
GLATTELAST COMPRESSION STOCKINGS
K841215 · DWL
Baurs Krey Assoc., Inc.
General Hospital · 77d
Cleared Jun 07, 1984
KMA-1300F
K841370 · BSZ
Medimex, Inc.
Anesthesiology · 65d
Cleared Jun 07, 1984
NEUROPACK 8 MEE 4108
K841497 · GWK
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Jun 07, 1984
NEUROPACK II 5100
K841612 · GWL
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Jun 07, 1984
ENTERAL NUTRITION PUMP
K841630 · FRN
Superior Plastic Products Corp.
General Hospital · 49d
Cleared Jun 07, 1984
MAST LUMINESCENT ALLERGY SYS
K841642 · DGC
Mast Immunosystems
Immunology · 48d
Cleared Jun 07, 1984
DRIGALSKI LITMUS LACTOSE AGAR
K841659 · JSF
Oxoid U.S.A., Inc.
Microbiology · 45d
Cleared Jun 07, 1984
MAXIMUM RECOVERY DILUENT
K841662 · JSG
Oxoid U.S.A., Inc.
Microbiology · 45d
Cleared Jun 07, 1984
Q.P. PREAMPLIFIER SYS
K841683 · GWQ
Bio-Scan, Inc.
Neurology · 45d
Cleared Jun 07, 1984
BIO/SCAN BIOLOG CASSETTE RECORDER
K841684 · GWQ
Bio-Scan, Inc.
Neurology · 45d
Cleared Jun 07, 1984
EEG ELECTRODES
K841685 · GXY
Bio-Scan, Inc.
Neurology · 45d
Cleared Jun 07, 1984
DEMAND C02
K841726 · KHS
Cooper Biomedical, Inc.
Chemistry · 43d
Cleared Jun 07, 1984
UROLOGICAL CATHETER & ACCESSORIES
K841727 · KOD
Research Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 07, 1984
MANNITOL SALT AGAR
K841747 · JSI
The Montana Deaconess Medical Center
Microbiology · 41d
Cleared Jun 07, 1984
XYLOSE-LYSINE DESOXYCHOLATE AGAR
K841752 · JSI
The Montana Deaconess Medical Center
Microbiology · 41d
Cleared Jun 07, 1984
MACCONKEY AGAR
K841753 · JSI
The Montana Deaconess Medical Center
Microbiology · 41d
Cleared Jun 07, 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · FRN
Abbott Laboratories
General Hospital · 38d
Cleared Jun 07, 1984
COOPER LASERSONICS ND:YAG LASER 8000
K841793
Cooper Lasersonics, Inc.
Cardiovascular · 38d
Cleared Jun 07, 1984
WI-38
K841806 · KIR
Viromed Laboratories, Inc.
Pathology · 37d
Cleared Jun 07, 1984
PHARMACIA IGE RIA
K841824 · DGC
Pharmacia, Inc.
Immunology · 36d
Cleared Jun 07, 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · DGC
Pharmacia, Inc.
Immunology · 35d
Cleared Jun 07, 1984
AMER. MED. OPTICS ARGON/KRYPTON LASER
K841856 · HQF
American Medical Optics
Ophthalmic · 35d
Cleared Jun 07, 1984
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
K841892 · CIG
Reagents Applications, Inc.
Chemistry · 31d
Cleared Jun 07, 1984
SPECTACLE FRAMES
K841908 · HQZ
Cosmas Optical USA , Ltd.
Ophthalmic · 30d