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
97561–97584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1996
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
K960957 · FRN
Sims Deltec, Inc.
General Hospital · 85d
Cleared Jun 04, 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · DHR
Bio-Rad
Immunology · 85d
Cleared Jun 04, 1996
QUANTEC SERIES 2000 ENDODONTIC FILES
K962031 · EKS
Tycom Dental
Dental · 11d
Cleared Jun 03, 1996
3030 INFUSION PUMP
K955258 · FRN
Sabratek Corp.
General Hospital · 200d
Cleared Jun 03, 1996
RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
K955687 · JAA
Contour Fabricators of Florida, Inc.
Radiology · 172d
Cleared Jun 03, 1996
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
K960086 · GEX
Slt-J , Ltd.
General & Plastic Surgery · 144d
Cleared Jun 03, 1996
THE COBALT SCALPEL
K960892 · IWB
Nova Therapeutic System
Radiology · 90d
Cleared Jun 03, 1996
SDL DIODE LASER SYSTEM
K960905 · GEX
Slt-J , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 03, 1996
UPACS
K960941 · LMB
Base Ten Systems, Inc.
Radiology · 87d
Cleared Jun 03, 1996
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K961097 · GEI
Debusk Knitting Mills, Div. Deroyal...
General & Plastic Surgery · 76d
Cleared Jun 03, 1996
PULSEMASTER
K961136 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 74d
Cleared Jun 03, 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL...
K961351 · DHA
Bayer Corp.
Chemistry · 59d
Cleared Jun 03, 1996
LACTATE DEHYDROGENASE REAGENT SET
K961431 · CFJ
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Jun 03, 1996
WHEELED STRETCHER
K961437 · FPO
Hill-Rom, Inc.
General Hospital · 49d
Cleared Jun 03, 1996
U-DOA CONTROLS
K961724 · DIF
Medical Diagnostic Technologies, Inc.
Toxicology · 31d
Cleared Jun 01, 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485 · HRS
Howmedica Corp.
Orthopedic · 44d
Cleared May 31, 1996
LARYNGOSCOPE COVER
K945301 · CCW
Sotiria Mourkidou, M.D.
Anesthesiology · 578d
Cleared May 31, 1996
SPACELABS MEDICAL MULTIGAS ANALYZER
K954962 · CBR
Spacelabs, Inc.
Anesthesiology · 214d
Cleared May 31, 1996
ACTICOAT SILVER COATED DRESSING
K955453 · KMF
Westaim Technologies, Inc.
General & Plastic Surgery · 184d
Cleared May 31, 1996
MISTRAL SUNGLASSES
K960668 · HQY
Mistral Optical
Ophthalmic · 101d
Cleared May 31, 1996
SUNGLASSES
K960818 · HQY
Visard Srl
Ophthalmic · 93d
Cleared May 31, 1996
SUNGLASSES
K960953 · HQY
Galilee Optics
Ophthalmic · 81d
Cleared May 31, 1996
AS/3 CARDIAC OUTPUT & SVO2 MODULE
K961063 · DQK
Datex Medical Instrumentation, Inc.
Cardiovascular · 74d
Cleared May 31, 1996
SUNGLASSES
K961146 · HQY
Erica Optical Co.
Ophthalmic · 71d