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
128113–128136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1989
BLUNT NEEDLE PORT/I.V. PORT
K895480 · FPA
Applied Medical Technologies
General Hospital · 81d
Cleared Dec 01, 1989
LATEX PATIENT EXAMINATION GLOVES
K895488 · LYY
Zhong YI Latex Products Factory
General Hospital · 91d
Cleared Dec 01, 1989
MILENIA(TM) HCG (MKCG1,5)
K895809 · JHI
Diagnostic Products Corp.
Chemistry · 90d
Cleared Dec 01, 1989
NEEDLEPOINT GUARD
K895831 · FMF
Needlepoint Guard, Inc.
General Hospital · 60d
Cleared Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
K895870 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Dec 01, 1989
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
K895886 · KWL
Biopro, Inc.
Orthopedic · 57d
Cleared Dec 01, 1989
IMMUNOCARD HCG II-S TEST KIT
K895912 · JHI
Disease Detection International, Inc.
Chemistry · 52d
Cleared Dec 01, 1989
STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
K896135 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 43d
Cleared Dec 01, 1989
SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
K896163 · FGE
Schneider Stent
Gastroenterology & Urology · 38d
Cleared Dec 01, 1989
ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
K896196 · HRX
Orthoconcept, Inc.
Orthopedic · 37d
Cleared Dec 01, 1989
OSBON PERSONAL LUBRICANT
K896207 · KMJ
Osbon Medical Systems, Ltd.
General Hospital · 36d
Cleared Dec 01, 1989
INJECTION PORT II --- FOR INTERMITTENT INJECTION
K896291 · FPA
The Medi-Dose Group
General Hospital · 31d
Cleared Dec 01, 1989
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · DEB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 18d
Cleared Dec 01, 1989
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
K896545 · GFO
Sigma Chemical Co.
Hematology · 14d
Cleared Nov 30, 1989
STERILE FOLEY CATHETER
K890310 · EYC
Kosan Far East Ent. , Ltd.
Gastroenterology & Urology · 311d
Cleared Nov 30, 1989
TON-SU'S VINYL EXAM GLOVES
K892584 · LYZ
Ton SU Co. , Ltd.
General Hospital · 232d
Cleared Nov 30, 1989
IFA SENSIBAC CEFACLOR
K892721 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 230d
Cleared Nov 30, 1989
SPACELABS MODEL 90900
K894093 · LOS
Spacelabs, Inc.
Cardiovascular · 174d
Cleared Nov 30, 1989
ANGEION HEMOSTASIS VALVE INTRODUCER
K894446 · DYB
Angeion Corp.
Cardiovascular · 136d
Cleared Nov 30, 1989
CARRINGTON DERMAL WOUND GEL
K894541 · FRO
Carrington Laboratories, Inc.
General & Plastic Surgery · 133d
Cleared Nov 30, 1989
16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
K894878 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
K894879 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
K894880 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K894881 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d