FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
112369–112392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1993
SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE
K931185 · CCC
Optical Sensors, Inc.
Anesthesiology · 226d
Cleared Oct 21, 1993
POWDER-FREE PATIENT EXAMINATION GLOVES
K931406 · LYY
P.T. Healthcare Glovindo
General Hospital · 216d
Cleared Oct 21, 1993
GLENN BED
K931581 · FNL
Kinetic Concepts, Inc.
General Hospital · 205d
Cleared Oct 21, 1993
MODEL EP-2 CLINICAL STIMULATOR
K933069 · DTA
Ep Medical, Inc.
Cardiovascular · 121d
Cleared Oct 21, 1993
KNOT PUSHER
K933243 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 111d
Cleared Oct 21, 1993
BRIMFIELD PRECISION SCISSOR
K933388 · GCJ
Springfield Surgical Instruments
General & Plastic Surgery · 101d
Cleared Oct 21, 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
K934357 · JJY
Bio-Rad
Chemistry · 43d
Cleared Oct 21, 1993
KOKO FILTER II
K934475 · CAH
Pulmonary Data Services Inst., Inc.
General Hospital · 37d
Cleared Oct 21, 1993
PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER
K934509 · CAH
Sdi Diagnostics, Inc.
General Hospital · 37d
Cleared Oct 20, 1993
AMDENT 2030, POLISHER/SCALER
K920328 · ELC
Amdent AB
Dental · 636d
Cleared Oct 20, 1993
ORMCO SPORTSGUARD
K922806 · EJF
Ormco Corp.
Dental · 497d
Cleared Oct 20, 1993
BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP.
K925767 · DZE
Nobelpharma USA, Inc.
Dental · 338d
Cleared Oct 20, 1993
AUKUSLEEVE
K930094 · EJB
Aukland Medical Plastics, Inc.
Dental · 285d
Cleared Oct 20, 1993
MODISSA 90 S.R.L. SUNGLASSES
K930858 · HQY
Modissa 90 Srl
Ophthalmic · 244d
Cleared Oct 20, 1993
SIGMA-BRILLEN (OR) MULTIPLE
K930956 · HQZ
Sigma-Brillen
Ophthalmic · 239d
Cleared Oct 20, 1993
DW232 #31
K932774 · EJT
Invoclar North America, Inc.
Dental · 134d
Cleared Oct 20, 1993
NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE
K933150 · DZE
Nobelpharma USA, Inc.
Dental · 113d
Cleared Oct 20, 1993
A-DEC 2611 ASSISTANT'S CART
K933166 · EIA
A-Dec, Inc.
Dental · 113d
Cleared Oct 20, 1993
RESIMENT WITH FLUORIDE
K933459 · EMA
J.L. Blosser, Inc.
Dental · 98d
Cleared Oct 20, 1993
EYEGLASSES FRAMES
K933529 · HQZ
Vistula Assistance & Consulting Bureau
Ophthalmic · 92d
Cleared Oct 20, 1993
INTRA-ORAL IRRIGATOR
K933547 · ELC
Parkell, Inc.
Dental · 90d
Cleared Oct 20, 1993
VS 1A
K933563 · EJS
Metalor Dental USA Corp.
Dental · 90d
Cleared Oct 20, 1993
PROFILE SERIES 29 FILES
K933582 · EKS
Tulsa Dental Products, Ltd.
Dental · 89d
Cleared Oct 19, 1993
HAN-D-AID
K924793 · FMI
Salmon Ent.
General Hospital · 391d