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
145225–145248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1986
I/A - VFE SYSTEM II
K854868 · HQE
Mira, Inc.
Ophthalmic · 65d
Cleared Feb 07, 1986
MICRO SURGICAL SYSTEM
K854871 · HQE
Mira, Inc.
Ophthalmic · 65d
Cleared Feb 07, 1986
NIDEK AC-2000 LASER SYSTEM
K860011 · HQB
Nidek, Inc.
Ophthalmic · 35d
Cleared Feb 07, 1986
ACROMED CANCELLOUS BONE SCREW
K860017 · HWC
Buckman Co., Inc.
Orthopedic · 35d
Cleared Feb 07, 1986
FISCHER WIRE/PIN CLAMP
K860018 · HXK
Buckman Co., Inc.
Orthopedic · 35d
Cleared Feb 07, 1986
WINK-EASE DISPOSABLE PROTECTIVE
K860043 · HQY
Eye Pro Medical Products, Inc.
Ophthalmic · 32d
Cleared Feb 07, 1986
SLUSH PAN COVER
K860065
O.R. Concepts, Inc.
General & Plastic Surgery · 32d
Cleared Feb 07, 1986
VIS-2000 VIDEO SYSTEM
K860173 · FWG
Vistek Corp.
General & Plastic Surgery · 21d
Cleared Feb 06, 1986
MEVASSIST(SETUP CONTROLLER)
K852609 · IYE
Magus Microcontrollers, Inc.
Radiology · 232d
Cleared Feb 06, 1986
CARDIMAX FX-1164
K853979 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 133d
Cleared Feb 06, 1986
DIESSE RF TEST KIT
K854222 · DHR
Marvic Interpharma, Inc.
Immunology · 111d
Cleared Feb 06, 1986
THE BLEDSOE PASSIVE MOTION EXERCISER
K854354 · BXB
Medical Technology and Innovations, Inc.
Physical Medicine · 100d
Cleared Feb 06, 1986
ADAM (ABSORBENT INCONTINENCE SHIELD)
K854729 · EYQ
Lic-Orthion
Gastroenterology & Urology · 73d
Cleared Feb 06, 1986
DAISY (ABSORBENT INCONTINENCE SHIELD)
K854730 · EYQ
Lic-Orthion
Gastroenterology & Urology · 73d
Cleared Feb 06, 1986
EIA PROCESSOR
K854936 · JJE
Abbott Laboratories
Chemistry · 58d
Cleared Feb 06, 1986
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
K854971 · KLI
V-Tech, Inc.
Chemistry · 57d
Cleared Feb 06, 1986
TABLE RADIOGRAPHIC FIXED
K855052 · IXQ
X-Ray Systems
Radiology · 51d
Cleared Feb 06, 1986
T3 UPTAKE RADIOIMMUNOASSAY KIT
K855169 · KHQ
Cambridge Medical Technology
Chemistry · 42d
Cleared Feb 06, 1986
LDH (OPTIMIZED) REAGENT
K860029 · CFJ
Sigma Chemical Co.
Chemistry · 31d
Cleared Feb 06, 1986
QWIK-CALL
K860052 · KNT
Emde Corp.
Gastroenterology & Urology · 31d
Cleared Feb 06, 1986
ENZYMATIC UREA NITROGEN REAGENT SET
K860109 · CDQ
Technostics Intl.
Chemistry · 24d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Feb 06, 1986
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
K860140 · LAN
American Dade
Toxicology · 23d
Cleared Feb 06, 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154 · CDL
Sterling Diagnostics, Inc.
Chemistry · 21d