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
146137–146160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1985
INTEGRATED DISPLAY TECHNOLOGY LTD.
K853130 · FLL
Integrated Display Technology, Ltd.
General Hospital · 105d
Cleared Nov 08, 1985
OE SERIES OF BEHIND-THE-EAR HEARING AIDS
K853381 · ESD
Emtech Laboratories
Ear, Nose, Throat · 88d
Cleared Nov 08, 1985
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444 · JAK
Toshiba Medical Systems
Radiology · 84d
Cleared Nov 08, 1985
DIGITAL THERMOMETER
K853824 · FLL
Epson America, Inc.
General Hospital · 56d
Cleared Nov 08, 1985
ALPHA CHUCK
K853970 · KME
Rocky Mountain Medical Corp.
General Hospital · 43d
Cleared Nov 08, 1985
MICROTHERM MT-501 & MT-502
K854007 · FLL
Medequi, Division of King Yip Co., Inc.
General Hospital · 39d
Cleared Nov 08, 1985
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
K854084 · FKL
Organon Teknika Corp.
Gastroenterology & Urology · 32d
Cleared Nov 08, 1985
EXPRESS TAN SUN CANOPY
K854111 · FTC
Sunmaker Tanning Systems, Ltd.
General & Plastic Surgery · 31d
Cleared Nov 08, 1985
PHASE V-MODEL 1500 RUVA
K854131 · FTC
Apollo'S Suntanning Supplies
General & Plastic Surgery · 29d
Cleared Nov 08, 1985
FOX BED MODEL 2001
K854154 · FTC
Ace Mfg.
General & Plastic Surgery · 28d
Cleared Nov 08, 1985
I.S.M. PRODUCT FAMILY MODEL R3600C
K854170 · FTC
Intl. Solarium Manufacturer, Inc.
General & Plastic Surgery · 24d
Cleared Nov 08, 1985
GOLDEN RULE SUN TANNING BEDS
K854224 · FTC
Golden Rule Tanning Co., Inc.
General & Plastic Surgery · 21d
Cleared Nov 08, 1985
CHURCHILL 3-WAY STOPCOCK SET
K854348 · FMG
Churchill Corp.
General Hospital · 10d
Cleared Nov 07, 1985
HEARING AID(ALL IN EAR)
K852244 · ESD
Olympia Instruments, Inc.
Ear, Nose, Throat · 168d
Cleared Nov 07, 1985
ECHO TYPE 16 CF ANTIGEN
K853156 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
ECHO TYPE 11 CF ANTIGEN
K853157 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
THE VICKERS STANDARD MICROSURGERY SET
K853161 · GZX
Keeler Instruments, Inc.
Neurology · 100d
Cleared Nov 07, 1985
ECHO TYPE 30 CF ANTIGEN
K853165 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND
K853179 · GZX
Keeler Instruments, Inc.
Neurology · 100d
Cleared Nov 07, 1985
CMV CF ANTIGEN
K853277 · GQI
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
POLIO TYPE I CF ANTIGEN, & TYPE II, III
K853278 · GOG
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
COXSACKIE A2 CF ANTIGEN, A4, A10 & A16
K853279 · GNO
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
MES-TENS(TENS)
K853416 · GZJ
Oriental Medical Supplies, Inc.
Neurology · 85d
Cleared Nov 07, 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · DYH
Dentsply Intl.
Dental · 77d