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
92881–92904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1997
AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD
K971540 · GEI
American Biosurgical, Inc.
General & Plastic Surgery · 108d
Cleared Aug 14, 1997
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542 · IPF
Rehabilicare, Inc.
Physical Medicine · 108d
Cleared Aug 14, 1997
SCULPTURE
K971609 · LFL
Servizi Medico Estetici Italinai Srl.
General & Plastic Surgery · 105d
Cleared Aug 14, 1997
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM
K971830 · GEX
Argus Photonics Group
General & Plastic Surgery · 90d
Cleared Aug 14, 1997
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER
K971879 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 14, 1997
AQUA SPRAY
K971941 · GEY
Boyd Industries, Inc.
General & Plastic Surgery · 79d
Cleared Aug 14, 1997
CONFOSCAN
K971953 · HJO
Tomey Corporation USA
Ophthalmic · 78d
Cleared Aug 14, 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE...
K972054 · KPI
Empi
Gastroenterology & Urology · 73d
Cleared Aug 14, 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 72d
Cleared Aug 14, 1997
Cordis Endeavor Infusion Catheter
K972110 · QEY
Cordis Corp.
Cardiovascular · 70d
Cleared Aug 14, 1997
DEXON VIOLET
K972566 · GAM
Davis & Geck, Inc.
General & Plastic Surgery · 36d
Cleared Aug 14, 1997
PIVOTING COMPENSATING FILTERS FOR THE HEAD
K972766 · KPR
Octostop, Inc.
Radiology · 21d
Cleared Aug 13, 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · DPS
Quinton, Inc.
Cardiovascular · 259d
Cleared Aug 13, 1997
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971632 · JTN
Oxoid , Ltd.
Microbiology · 103d
Cleared Aug 13, 1997
ALICE 4R SYSTEM
K971867 · OLV
Healthdyne Technologies, Inc.
Neurology · 85d
Cleared Aug 13, 1997
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
K972005 · GGP
Reaads Medical Products, Inc.
Hematology · 75d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182 · MJZ
Abbott Diagnostics
Microbiology · 76d
Cleared Aug 13, 1997
REAADS PROTEIN S ANTIGEN TEST KIT
K972482 · GGP
Reaads Medical Products, Inc.
Hematology · 42d
Cleared Aug 13, 1997
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN...
K972627 · GJT
Pacific Hemostasis
Hematology · 30d
Cleared Aug 13, 1997
VIGIL TDM CONTROLS
K972819 · DIF
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Aug 12, 1997
ECG REVIEW STATION
K942685 · DXJ
Mortara Instrument, Inc.
Cardiovascular · 1162d
Cleared Aug 12, 1997
IMZ TWIN PLUS SCREW
K963520 · DZE
Imz, GmbH
Dental · 343d
Cleared Aug 12, 1997
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K970511 · HRX
Smith & Nephew, Inc.
Orthopedic · 182d
Cleared Aug 12, 1997
DERMAGRAN WOUND MANAGEMENT SYSTEM
K970660 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 172d