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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81649–81672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2000
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K001078 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 80d
Cleared Jun 23, 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP)...
K001107 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 79d
Cleared Jun 23, 2000
AUDIO TECHNOLOGIES S:R.1
K001142 · ETB
Audio Technologies S.R.L.
Ear, Nose, Throat · 74d
Cleared Jun 23, 2000
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
K001172 · GAT
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · GAR
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · GAP
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185 · GAW
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
ACULUX, MODEL AX3001, AX3002
K001223 · FQP
Aculux
General & Plastic Surgery · 67d
Cleared Jun 23, 2000
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING...
K001274 · KGO
Pt. Maja Agung Latexindo
General Hospital · 64d
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 23, 2000
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
K001299 · GAL
Cp Medical
General & Plastic Surgery · 60d
Cleared Jun 23, 2000
PALCERAM 49
K001481 · EJT
Aurex SA (Pty) , Ltd.
Dental · 43d
Cleared Jun 23, 2000
AURENORM 75 KF
K001482 · EJT
Aurex SA (Pty) , Ltd.
Dental · 43d
Cleared Jun 23, 2000
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
K001601 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 30d
Cleared Jun 23, 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
K001637 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 24d
Cleared Jun 23, 2000
BIOSOFT RESIN
K001640 · EBI
Biosoft International Corp.
Dental · 46d
Cleared Jun 23, 2000
VARIS 1.4G
K001643 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 23, 2000
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
K001649 · JOJ
Steritec Products, Inc.
General Hospital · 24d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · KKX
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Jun 23, 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 22d
Cleared Jun 23, 2000
GALILEO VENTILATOR
K001686 · CBK
Hamilton Medical, Inc.
Anesthesiology · 36d
Cleared Jun 23, 2000
GEMINI E
K993623 · DQD
Allen Medical Instruments Corp.
Cardiovascular · 241d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST (THC)
K993663 · LDJ
Worldwide Medical Corp.
Toxicology · 238d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138 · LDJ
Worldwide Medical Corp.
Toxicology · 199d