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
111721–111744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1993
SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES
K934122 · DQX
Scimed Peripheral Interventions
Cardiovascular · 43d
Cleared Oct 07, 1993
MAVIG ANGIO SHIELD MODELS 6290 & 6272
K934206 · KPY
F. Walter Hanel GmbH
Radiology · 38d
Cleared Oct 07, 1993
SCIMED STRIKE STEERABLE GUIDE WIRE
K934359 · DQX
Scimed Peripheral Interventions
Cardiovascular · 29d
Cleared Oct 06, 1993
IMPLANTABLE PULSE GENERATORS
K925106 · DYX
Medtronic Vascular
Dental · 362d
Cleared Oct 06, 1993
BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
K931106 · CAC
Deknatel, Inc.
Anesthesiology · 217d
Cleared Oct 06, 1993
ITEM # 754 HOT FLIP SHADES
K931389 · HQY
Ja-Ru, Inc.
Ophthalmic · 202d
Cleared Oct 06, 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479 · DQO
Mallinckrodt Medical
Cardiovascular · 196d
Cleared Oct 06, 1993
MULTI-PORT Y INTRODUCER SET
K931587 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 189d
Cleared Oct 06, 1993
NEUTRALIZER
K932320 · GZJ
Smith and Nephew Donjoy, Inc.
Neurology · 148d
Cleared Oct 06, 1993
HOMEPUMP NSF
K932740 · MED
Block Medical, Inc.
General Hospital · 120d
Cleared Oct 06, 1993
SUNGLASSES AND OPTICAL FRAMES, CARBON AND METAL FRAMES
K932838 · HQY
Wonderful Optical Co., Ltd.
Ophthalmic · 117d
Cleared Oct 06, 1993
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · BTR
Bivona Medical Technologies
Anesthesiology · 86d
Cleared Oct 06, 1993
MULTIPLE
K933452 · HQZ
Tae Han Optical Ent.
Ophthalmic · 85d
Cleared Oct 06, 1993
CAPNO-FLO
K933626 · BTM
Kirk Specialty Systems
Anesthesiology · 82d
Cleared Oct 06, 1993
MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER...
K933975 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 54d
Cleared Oct 05, 1993
SOFTCUP(TM):2
K920792 · HHE
Ultrafem, Inc.
Obstetrics & Gynecology · 592d
Cleared Oct 05, 1993
PORT OPII, PORT OPIII
K923354 · EIA
Mobile Dental Equipment Corp.
Dental · 454d
Cleared Oct 05, 1993
HYPOGRIP(TM)
K924820 · FMI
Collett Products
General Hospital · 372d
Cleared Oct 05, 1993
BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE
K925760 · DZE
Nobelpharma USA, Inc.
Dental · 326d
Cleared Oct 05, 1993
BRANEMARK SYSTEM 5.0 X 14MM FIXTURE
K925761 · DZE
Nobelpharma USA, Inc.
Dental · 326d
Cleared Oct 05, 1993
BRANEMARK SYSTEM 4.00 MM FIXTURE
K925764 · DZE
Nobelpharma USA, Inc.
Dental · 326d
Cleared Oct 05, 1993
BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE
K925765 · DZE
Nobelpharma USA, Inc.
Dental · 326d
Cleared Oct 05, 1993
POWDER-FREE EXAMINATION GLOVE
K926440 · LYY
Slim River Latex Sdn. Bhd.
General Hospital · 286d
Cleared Oct 05, 1993
BRANEMARK SYSTEM(R) - 5.5MM FIXTURE
K926501 · DZE
Nobelpharma USA, Inc.
Dental · 280d