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
75145–75168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2002
EBI AIS SPINE SYSTEM
K020887 · MQP
Ebi, L.P.
Orthopedic · 59d
Cleared May 16, 2002
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
K020927 · LPL
Bausch & Lomb
Ophthalmic · 56d
Cleared May 16, 2002
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K020956 · MUI
Microtek Medical, Inc.
Radiology · 52d
Cleared May 16, 2002
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K021001 · LZA
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 49d
Cleared May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
K021024 · GGN
Instrumentation Laboratory CO
Hematology · 48d
Cleared May 16, 2002
EBI XFIX RAIL SYSTEM
K021031 · KTT
Ebi, L.P.
Orthopedic · 48d
Cleared May 16, 2002
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L...
K021092 · FTC
Philips Lighting Co.
General & Plastic Surgery · 42d
Cleared May 16, 2002
ACCOMMODATOR WHEELCHAIR, MODEL #2000X
K021145 · IOR
Marken International, Inc.
Physical Medicine · 37d
Cleared May 16, 2002
QACA IGG/IGM ELISA KIT HRP
K021192 · MID
Cheshire Diagnostics , Ltd.
Immunology · 31d
Cleared May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · MTD
Boston Scientific Corp
Cardiovascular · 28d
Cleared May 16, 2002
PORTALLOY 54
K021242 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 27d
Cleared May 16, 2002
STERNGOLD 66, MODEL #1180230
K021367 · EJS
Sterngold
Dental · 16d
Cleared May 16, 2002
SUNSPEX TECHNOLOGIES MODEL SE 02
K021371 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 16d
Cleared May 16, 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · JEY
Synthes (Usa)
Dental · 14d
Cleared May 16, 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES,...
K021396 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 14d
Cleared May 16, 2002
PHILIPS PLS9W/12/2P UVB
K021514 · FTC
Philips Lighting Co.
General & Plastic Surgery · 7d
Cleared May 15, 2002
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · DWL
Boehringer Laboratories
General Hospital · 85d
Cleared May 15, 2002
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
K020633 · HIS
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 77d
Cleared May 15, 2002
HERNIAMESH T-SLING
K020652 · PAH
Herniamesh
Gastroenterology & Urology · 76d
Cleared May 15, 2002
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
K020726 · HIB
Dukal Corp.
Obstetrics & Gynecology · 70d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · DIO
ACON Laboratories, Inc.
Toxicology · 68d
Cleared May 15, 2002
VITAL SCIENTIFIC PT WITH CALCIUM
K020840 · GJS
Vital Scientific N.V.
Hematology · 61d
Cleared May 15, 2002
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · JTN
Becton, Dickinson & CO
Microbiology · 61d
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 58d