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
133489–133512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1988
CDT CYTOTOXI TEST
K883560 · LLH
Advanced Clinical Diagnostics
Microbiology · 67d
Cleared Oct 25, 1988
MODIFIED REUSABLE SITE FIBER OPTIC CABLE
K883605 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 63d
Cleared Oct 25, 1988
I-SPOSE EYE SHIELD
K883658 · FXX
Products For Medicine
General Hospital · 60d
Cleared Oct 25, 1988
RUBELLA IGM MICROASSAY
K883778 · LFX
Diamedix Corp.
Microbiology · 49d
Cleared Oct 25, 1988
FIBER OPTIC LARYNGOSCOPE
K883830 · CCW
Effner, Inc.
Anesthesiology · 46d
Cleared Oct 25, 1988
QLIA T UPTAKE ASSAY
K883971 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Oct 25, 1988
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
K883975 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 35d
Cleared Oct 25, 1988
ADD-A-CATH
K884061 · KOB
Femcare , Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 25, 1988
SNAP N' STAIN IODINE STAIN
K884069 · JTS
Scientific Device Laboratory, Inc.
Pathology · 28d
Cleared Oct 25, 1988
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
K884208 · KZI
Oxoid U.S.A., Inc.
Microbiology · 19d
Cleared Oct 24, 1988
BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000
K883129 · KHX
Advanced Mechanical Technology, Inc.
Physical Medicine · 90d
Cleared Oct 24, 1988
BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000
K883130 · KHX
Advanced Mechanical Technology, Inc.
Physical Medicine · 90d
Cleared Oct 24, 1988
BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000
K883131 · KHX
Advanced Mechanical Technology, Inc.
Physical Medicine · 90d
Cleared Oct 24, 1988
BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM
K883198 · KHX
Advanced Mechanical Technology, Inc.
Physical Medicine · 88d
Cleared Oct 24, 1988
#875 DISPOSABLE BIOPOLAR CABLE
K884171 · HAM
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 24d
Cleared Oct 24, 1988
MODIFIED OLSEN #770 DISPOSABLE HOLSTER
K884172 · HAM
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 24d
Cleared Oct 24, 1988
#920 DISPOSABLE TUR CABLE
K884173 · HAM
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 24d
Cleared Oct 24, 1988
MODIFIED OLSEN 755/756 SWITCHPENS
K884174 · HAM
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 24d
Cleared Oct 24, 1988
#820/821 BIPOLAR FORCEPS
K884175 · HAM
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 24d
Cleared Oct 24, 1988
GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)
K884195 · GEN
Mumtaz I. Malik
General & Plastic Surgery · 18d
Cleared Oct 21, 1988
INTROCULAR FLUID INJECTOR
K881707 · FIH
B&B Medical Assoc., Inc.
Gastroenterology & Urology · 193d
Cleared Oct 21, 1988
REPORT AND IMAGE MANAGEMENT SYSTEM
K882754 · LMD
Medical Image Processing Specialists,...
Radiology · 108d
Cleared Oct 21, 1988
BARD URETEROSCOPIC DEVICE
K883110 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 21, 1988
HIMOBILIX 2N
K883161 · JAA
Bay X-Ray, Inc.
Radiology · 87d