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
92905–92928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1997
SUNGLASSES
K971462 · HQY
D.G. Prove Co.
Ophthalmic · 71d
Cleared Jul 01, 1997
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING,...
K971472 · FTL
Technical Products, Inc.
General & Plastic Surgery · 69d
Cleared Jul 01, 1997
RESTRAINTS (VESTS AND JACKETS)
K971536 · FMQ
E.M. Adams Co., Inc.
General Hospital · 64d
Cleared Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
K971861 · LFL
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared Jun 30, 1997
PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)
K963578 · DPS
Intl. Products, Inc.
Cardiovascular · 297d
Cleared Jun 30, 1997
DIASCOPE TRAVELLER PLUS (4053)
K964593 · DSI
S & W Medico Teknik A/S
Cardiovascular · 227d
Cleared Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 189d
Cleared Jun 30, 1997
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K970420 · JQW
Pharmacia, Inc.
Chemistry · 147d
Cleared Jun 30, 1997
LASERSCOPE MICROBEAM IV MICROMANIPULATOR
K971250 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Jun 30, 1997
COULTER ACT TRON CELL CONTROL
K971469 · JPK
Coulter Corp.
Hematology · 69d
Cleared Jun 30, 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · KPI
Empi
Gastroenterology & Urology · 63d
Cleared Jun 30, 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · DZE
Straumann USA
Dental · 61d
Cleared Jun 30, 1997
MEDPOR OCULAR SCREW AND ACCEOSSORIES
K971583 · MQU
Porex Technologies Corp.
Ophthalmic · 61d
Cleared Jun 30, 1997
ETEST FOR CEFTAZIDIME
K971694 · JWY
Ab Biodisk
Microbiology · 54d
Cleared Jun 30, 1997
WELCH ALLYN PHACO ILLUMINATOR
K971750 · HQC
Welch Allyn, Inc.
Ophthalmic · 49d
Cleared Jun 30, 1997
HI DENSE TC
K971927 · EMA
Shofu Dental Corp.
Dental · 34d
Cleared Jun 30, 1997
RCT GEL ROOT CANAL THERAPY GEL
K972234 · EIC
Dentsply Intl.
Dental · 14d
Cleared Jun 27, 1997
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K963160 · PKL
Olympus America, Inc.
Gastroenterology & Urology · 317d
Cleared Jun 27, 1997
ENDOSCOPE
K964131 · FAM
Akos Biomedical, Inc.
Gastroenterology & Urology · 255d
Cleared Jun 27, 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS...
K965002 · LZO
Encore Orthopedics, Inc.
Orthopedic · 193d
Cleared Jun 27, 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE...
K970720 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 120d
Cleared Jun 27, 1997
LATEX EXAMINATION GLOVES, POWDER FREE
K970977 · LYY
Arista Medi Prima
General Hospital · 105d
Cleared Jun 27, 1997
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · KHO
Tosoh Medics, Inc.
Chemistry · 93d
Cleared Jun 27, 1997
ENCORE BOND
K971121 · KLE
Centrix, Inc.
Dental · 92d