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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68617–68640 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2004
CONDUCTIVITY/TDS CALIBRATOR SOLUTION
K033330 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 134d
Cleared Feb 27, 2004
POWER LED
K033697 · EBZ
Dental Products of USA, Inc.
Dental · 94d
Cleared Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
K033728 · HEW
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 91d
Cleared Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
K033771 · MKJ
Bio-Detek, Inc.
Cardiovascular · 86d
Cleared Feb 27, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND...
K033786 · JIT
Ibl GmbH
Chemistry · 85d
Cleared Feb 27, 2004
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · DHR
Zeus Scientific, Inc.
Immunology · 81d
Cleared Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879 · DKB
Maine Standards Co.
Toxicology · 74d
Cleared Feb 27, 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027 · MQN
KLS-Martin L.P.
Dental · 60d
Cleared Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
K040006 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Feb 27, 2004
CENTRAL STATION, VERSION 3.3H
K040032 · DXN
Hommed, LLC
Cardiovascular · 50d
Cleared Feb 27, 2004
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
K040129 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 27, 2004
ON-BOARD IMAGER DEVICE
K040192 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 27, 2004
EP-4 CLINICAL STIMULATOR
K040207 · JOQ
Ep Medsystems
Cardiovascular · 28d
Cleared Feb 27, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 28d
Cleared Feb 27, 2004
LYPHOCHEK HEMOSTASIS CONTROL
K040275 · GGN
Bio-Rad
Hematology · 22d
Cleared Feb 27, 2004
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
K040409 · IYN
Larsen & Toubro Limited
Radiology · 9d
Cleared Feb 26, 2004
EPICOR MEDICAL ABLATION SYSTEM
K022894 · NTB
Epicor Medical, Inc.
General & Plastic Surgery · 541d
Cleared Feb 26, 2004
ENVOY PATIENT MONITOR
K030722 · MHX
Mennen Medical, Inc.
Cardiovascular · 356d
Cleared Feb 26, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
K031097 · JXG
Sophysa SA
Neurology · 325d
Cleared Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · FOZ
Cook, Inc.
General Hospital · 218d
Cleared Feb 26, 2004
3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
K032555 · LLZ
Totoku Electric Co., Ltd.
Radiology · 191d
Cleared Feb 26, 2004
ORTHODONTIC COMPOSITE BRACKET SYSTEM
K032625 · DYW
Ultradent Products, Inc.
Dental · 184d
Cleared Feb 26, 2004
NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION...
K033086 · LZA
Pt. Medisafe Technologies
General Hospital · 150d
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · LLH
Remel, Inc.
Microbiology · 115d