FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92761–92784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA ABORTUS
K972394 · GSO
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP D
K972395 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA MELITENSIS
K972396 · GSO
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
EXTRAWEAR, GENTLEMEN'S CHOICE
K972428 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 59d
Cleared Aug 25, 1997
TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT
K972564 · ITI
Mechanical Application Designs, Inc.
Physical Medicine · 47d
Cleared Aug 25, 1997
RUFF WORK EYEGEAR
K972717 · HQY
Ruff House, Inc.
Ophthalmic · 35d
Cleared Aug 25, 1997
AURECAST 2
K972936 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 25, 1997
AURECAST 4
K972937 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 25, 1997
AURECAST 10
K972938 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 22, 1997
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · ETA
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 329d
Cleared Aug 22, 1997
DTX-200 BONE DENSITOMETER
K964562 · KGI
Osteometer Meditech A/S
Radiology · 282d
Cleared Aug 22, 1997
HEADLOC CERAMIC HEAD
K970675 · LZO
Ortho Development Corp.
Orthopedic · 179d
Cleared Aug 22, 1997
DRAPE, SURGICAL-LATEX
K970891 · KKX
Protek Medical Products, Inc.
General Hospital · 164d
Cleared Aug 22, 1997
WARMETTE
K971117 · LHC
Olympic Medical Corp.
General Hospital · 148d
Cleared Aug 22, 1997
CRT2000 THERMOGRAPHIC SYSTEM
K971956 · LHQ
Werner Eidam Medizin-Technologie GmbH
Radiology · 87d
Cleared Aug 22, 1997
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K972043 · GZB
Medtronic Vascular
Neurology · 81d
Cleared Aug 22, 1997
IMMULITE 2000 PSA
K972095 · LTJ
Diagnostic Products Corp.
Immunology · 79d
Cleared Aug 22, 1997
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K972443 · HQD
Menicon U.S.A., Inc.
Ophthalmic · 53d
Cleared Aug 22, 1997
LIFT MASTER
K972563 · ITI
Mechanical Application Designs, Inc.
Physical Medicine · 44d
Cleared Aug 22, 1997
CHASE BLOOD VESSEL SHUNT
K972665 · DWF
Chase Medical, Inc.
Cardiovascular · 37d
Cleared Aug 22, 1997
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · LKQ
Boston Biomedica, Inc.
Microbiology · 17d
Cleared Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577 · FOZ
Arrow Intl., Inc.
General Hospital · 416d
Cleared Aug 21, 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY...
K964907 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 255d
Cleared Aug 21, 1997
RID-DECUBE II
K965207 · FNM
Skin Care Management, Inc.
General Hospital · 237d