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
123529–123552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1990
NONPRESCRIPTION SUNGLASSES
K904281 · HQY
Jennie G. Sales Co., Inc.
Ophthalmic · 65d
Cleared Nov 21, 1990
CODMAN COLLINS RADIOPARENT STERNAL BLADES
K904352 · DWH
Codman & Shurtleff, Inc.
General & Plastic Surgery · 58d
Cleared Nov 21, 1990
MODEL 6/01 UV-B FIXTURE
K904425 · FTC
Strato-Ray Co.
General & Plastic Surgery · 55d
Cleared Nov 21, 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · DKZ
Diagnostic Products Corp.
Chemistry · 54d
Cleared Nov 21, 1990
ELASTOPLAST
K904500 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 50d
Cleared Nov 21, 1990
EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)
K904685 · FPA
Exel Intl.
General Hospital · 48d
Cleared Nov 21, 1990
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · KOD
Baxter Healthcare Corp
Gastroenterology & Urology · 35d
Cleared Nov 21, 1990
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
K905109 · FMC
Tactyl Technologies, Inc.
General Hospital · 8d
Cleared Nov 20, 1990
SYRINGE NEEDLE INTRODUCER
K901803 · KZH
Glaxo, Inc.
General Hospital · 215d
Cleared Nov 20, 1990
MEDICAL PROCEDURE TRAY
K902410 · LDQ
Sorex Medical
General & Plastic Surgery · 173d
Cleared Nov 20, 1990
STOMACH, GASTRO-ENTEROSTOMY
K902421 · KDH
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 173d
Cleared Nov 20, 1990
HEMODIALYSIS SYSTEM AND ACCESSORY
K902426 · FJK
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 173d
Cleared Nov 20, 1990
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 168d
Cleared Nov 20, 1990
MICROETCHER
K902836 · KOJ
Danville Engineering, Inc.
Dental · 145d
Cleared Nov 20, 1990
DEVICE PART NUMBER: SVD-3S DRILL
K902930 · DZE
Minimatic Implant Technology
Dental · 138d
Cleared Nov 20, 1990
TC-1111 TRANSFER PIN
K903044 · DZE
Minimatic Implant Technology
Dental · 132d
Cleared Nov 20, 1990
FREEVENT (TM)
K903057 · BYD
Pharma Systems, Inc.
Anesthesiology · 132d
Cleared Nov 20, 1990
TUBE GASTROSTOMY
K903086 · KGC
Knight Medical, Inc.
Gastroenterology & Urology · 131d
Cleared Nov 20, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30
K903318 · LNH
Summit World Trade Corp.
Radiology · 118d
Cleared Nov 20, 1990
KETONE TEST B SANWA STANDARD
K903366 · JIN
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
KETONE TEST A SANWA STANDARD
K903367 · JIN
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
ABO-1122 ANALOG BALL OVERDENTURE
K903518 · DZE
Minimatic Implant Technology
Dental · 109d
Cleared Nov 20, 1990
MAGNETIC RESONANCE DEVICE MRT 150A
K903768 · LNH
Toshiba America Mri, Inc.
Radiology · 92d
Cleared Nov 20, 1990
MRT 50A
K903770 · LNH
Toshiba America Mri, Inc.
Radiology · 92d