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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122545–122568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1991
ELECTROCAUTERY PROBE
K910334 · GEI
Wiltek Medical, Inc.
General & Plastic Surgery · 27d
Cleared Feb 21, 1991
PACIFIC MARQUIS SPA
K910607 · ILJ
Marquis International , Ltd.
Physical Medicine · 9d
Cleared Feb 20, 1991
SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900179 · DZE
Core-Vent Corp.
Dental · 400d
Cleared Feb 20, 1991
MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900181 · DZE
Core-Vent Corp.
Dental · 400d
Cleared Feb 20, 1991
INTHERM TEMPORARY OCCLUSION CATHETER
K901287 · DYG
Interventional Therapeutics Corp.
Cardiovascular · 337d
Cleared Feb 20, 1991
DIA IMPRESSION COPING
K902435 · DZE
Dental Imaging Assoc., Inc.
Dental · 265d
Cleared Feb 20, 1991
NITRATE DISK
K905163 · JTO
Remel Co.
Microbiology · 96d
Cleared Feb 20, 1991
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 92d
Cleared Feb 20, 1991
ASEPTIMINI UNIT, ADU-10
K905401 · EIA
Aseptico, Inc.
Dental · 79d
Cleared Feb 20, 1991
STOMADENT TM
K905476 · EBF
Dentsply Intl.
Dental · 76d
Cleared Feb 20, 1991
RETIC-CHEX
K905524 · JPK
Streck Laboratories, Inc.
Hematology · 72d
Cleared Feb 20, 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 65d
Cleared Feb 20, 1991
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · JEY
Walter Lorenz Surgical, Inc.
Dental · 47d
Cleared Feb 20, 1991
PHILIPS BV-29 IMAGING SYSTEM
K910115 · OXO
Philips Medical Systems, Inc.
Radiology · 41d
Cleared Feb 19, 1991
CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900180 · DZE
Core-Vent Corp.
Dental · 399d
Cleared Feb 19, 1991
ITC BUNJI COIL
K900723 · HCG
Interventional Therapeutics Corp.
Neurology · 369d
Cleared Feb 19, 1991
LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM
K903131 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 217d
Cleared Feb 19, 1991
SANDBOX I, SANDBOX II, SANDBOX JR.
K903321 · IRT
Sandbox Ent.
Physical Medicine · 209d
Cleared Feb 19, 1991
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · DXN
Hewlett-Packard Co.
Cardiovascular · 183d
Cleared Feb 19, 1991
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · HIS
Armkel, LLC
Obstetrics & Gynecology · 174d
Cleared Feb 19, 1991
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
K904169 · IZO
Varian Canada, Inc.
Radiology · 161d
Cleared Feb 19, 1991
SINGLE USE LAPARSCOPIC ELECTRODE
K904240 · HFG
Aspen Labs
Obstetrics & Gynecology · 159d
Cleared Feb 19, 1991
AUTODERM SCANNER CONTROL CONSOLE
K904266 · GEX
Charles I. Rose & Co., Inc.
General & Plastic Surgery · 154d
Cleared Feb 19, 1991
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
K904691 · HFM
Air-Shields Vickers, Inc.
Obstetrics & Gynecology · 126d