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
131281–131304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1989
EXTENSION SETS WITH AND WITHOUT FILTERS
K890176 · FPA
Medical Support Systems
General Hospital · 134d
Cleared Apr 26, 1989
QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA
K890267 · CHH
Photec Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 26, 1989
GLOVES, PATIENT EXAMINATION
K890344 · JTN
Tomarc (M) Sdn Bhd
Microbiology · 93d
Cleared Apr 26, 1989
MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
K890468 · GWM
Pearl Instruments Corp.
Neurology · 85d
Cleared Apr 26, 1989
LUXTEC ACO SERIES 4000 LIGHT SOURCE
K890716 · FCW
Luxtec Corp.
Gastroenterology & Urology · 72d
Cleared Apr 26, 1989
RIA-GNOST INSULIN
K890837 · CFP
Cambridge Medical Technology
Chemistry · 64d
Cleared Apr 26, 1989
ROYAL SHIELD LATEX EXAMINATION GLOVES(TM)
K890907 · LYY
Shield Gloves Manufacturer Sdn. Bhd....
General Hospital · 61d
Cleared Apr 26, 1989
ACA (R) DIGITOXIN CALIBRATOR
K891093 · DCJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 26, 1989
ACA(R) DIGITOXIN (DGTX) METHOD
K891094 · LFM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 26, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891223 · LYY
Sin Super Holdings Sdn Bhd
General Hospital · 50d
Cleared Apr 26, 1989
INTRAOPERATIVE RADIATION THERAPY DEVICES
K891261 · LHN
General Electric Co.
Radiology · 49d
Cleared Apr 26, 1989
'QUEST', 'PELANGI' PATIENT EXAM GLOVES (LATEX)
K891272 · LYY
Pelangi Rubber Products Sdn. Bhd.
General Hospital · 48d
Cleared Apr 26, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891304 · LYY
B & L Ent. Co.
General Hospital · 43d
Cleared Apr 26, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891305 · LYY
B & L Ent. Co.
General Hospital · 43d
Cleared Apr 26, 1989
STERILE SURGICAL GLOVES
K891308 · KGO
Carl Parker Associates, Inc.
General Hospital · 48d
Cleared Apr 26, 1989
LATEX EXAMINATION GLOVES, NON-STERILE
K891365 · LYY
China National Medicines & Health...
General Hospital · 47d
Cleared Apr 26, 1989
PROSHIELD GLOVE (LATEX)
K891426 · LYY
K & M Resources, Inc.
General Hospital · 43d
Cleared Apr 26, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K891441 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 42d
Cleared Apr 26, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891448 · LYY
Naturalex Rubber Products (M) Sdn Bhd
General Hospital · 42d
Cleared Apr 26, 1989
DSL 7900 ACTIVE DHEA-S (DSL #7900)
K891478 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 41d
Cleared Apr 26, 1989
FREEPINHO VINYL EXAM GLOVES
K891506 · LYZ
Reliance Industrial Co., Ltd.
General Hospital · 41d
Cleared Apr 26, 1989
WISE & SAFE PATIENT EXAMINATION GLOVES (LATEX)
K891659 · LYY
Wise Industries Sdn. Bhd.
General Hospital · 37d
Cleared Apr 26, 1989
ADVANCED PURIFICATION GLASS COLUMN
K891673 · DPM
Waters Chemical Products
Chemistry · 36d
Cleared Apr 26, 1989
LATEX EXAMINATION GLOVES, NON-STERILE
K891709 · LYY
Taiwan David, Inc.
General Hospital · 37d