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
70345–70368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2003
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
K031944 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 91d
Cleared Sep 23, 2003
PERSONNA PLUS SAFETY SCALPEL SYSTEM
K032242 · GES
Omi Manufacturing Pty., Ltd.
General & Plastic Surgery · 64d
Cleared Sep 23, 2003
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364 · FLL
Microlife Intellectual Property GmbH
General Hospital · 54d
Cleared Sep 23, 2003
F-11 FOLDING POWER CHAIR
K032440 · ITI
Wheelchair & Scooter Express
Physical Medicine · 47d
Cleared Sep 23, 2003
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468 · GAQ
Suturtek Incorporated
General & Plastic Surgery · 43d
Cleared Sep 23, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS...
K032553 · HCG
Cordis Neurovascular, Inc.
Neurology · 35d
Cleared Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...
K032606 · JWH
Exactech, Inc.
Orthopedic · 29d
Cleared Sep 23, 2003
BEELINE SYSTEM
K032642 · FRN
Mckinley, Inc.
General Hospital · 27d
Cleared Sep 23, 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · HCG
Boston Scientific Corp
Neurology · 21d
Cleared Sep 23, 2003
MODULAR PLUS HIP STEM
K032709 · LWJ
Plus Orthopedics
Orthopedic · 21d
Cleared Sep 23, 2003
EYESOPEN TONOMETER
K032769 · HKY
Eye-Deas, LLC
Ophthalmic · 15d
Cleared Sep 23, 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · FRN
Medrad, Inc.
General Hospital · 15d
Cleared Sep 23, 2003
DIAMOND D HIGH IMPACT DENTURE ACRYLIC
K032773 · EBI
Mycone Dental Supply Co., Inc.
Dental · 15d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833 · GXY
Otto Bock Healthcare LP
Neurology · 12d
Cleared Sep 22, 2003
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
K023983 · KWQ
Highgate Orthopaedics
Orthopedic · 294d
Cleared Sep 22, 2003
HALM ZIELKE INSTRUMENTATION SYSTEM
K024125 · KWQ
Micomed Ortho GmbH
Orthopedic · 280d
Cleared Sep 22, 2003
ESKA MODULAR HIP SYSTEM CEMENTED
K030867 · JDI
Eska Implants GmbH
Orthopedic · 187d
Cleared Sep 22, 2003
ULTRA-DRIVE 3
K031280 · JDX
Biomet, Inc.
Neurology · 153d
Cleared Sep 22, 2003
GLYCOMARK
K031604 · NOZ
Tomen America, Inc.
Chemistry · 123d
Cleared Sep 22, 2003
ALEXIS WOUND RETRACTOR
K031889 · KKX
Applied Medical Resources Corp.
General Hospital · 96d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K031955 · FTL
Macropore Biosurgery, Inc.
General & Plastic Surgery · 89d
Cleared Sep 22, 2003
MEDLINE BAND BAGS AND EQUIPMENT COVERS
K032065 · MMP
Medline Industries, Inc.
General Hospital · 81d
Cleared Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
K032110 · LWJ
Stelkast Company
Orthopedic · 75d