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
149329–149352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1985
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA
K850049 · HNN
Xtal Corp.
Ophthalmic · 57d
Cleared Mar 06, 1985
VERSA-FILL 120 & FILL SET 42-50
K850051 · LHI
Intl. Medical Industries
General Hospital · 57d
Cleared Mar 06, 1985
KM PRODUCTS SUCTION TIPS
K850240 · JOL
Km Products
General Hospital · 43d
Cleared Mar 06, 1985
WATERS 740 DATA MODULE-PLOTTER INTEGRATOR
K850272 · LDM
Millipore Corp.
Toxicology · 42d
Cleared Mar 06, 1985
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
K850576 · DTD
Pacesetter Systems
Cardiovascular · 21d
Cleared Mar 06, 1985
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
K850596 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 19d
Cleared Mar 06, 1985
INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS
K850645
Concept, Inc.
General & Plastic Surgery · 15d
Cleared Mar 06, 1985
C.A.D. PACK I -ARTHROSCOPY DRAPE PACK
K850714
Concept, Inc.
General & Plastic Surgery · 12d
Cleared Mar 05, 1985
ACCU-O-MATIC
K841427 · GZJ
Myomed, Inc.
Neurology · 333d
Cleared Mar 05, 1985
LIQUI-HEME HEMOGLOBIN CALIBRATORS
K842668 · KRZ
Biodiagnostic Intl
Chemistry · 238d
Cleared Mar 05, 1985
MAYO ELBOW II
K843778
Zimmer, Inc.
Orthopedic · 161d
Cleared Mar 05, 1985
ACCESS C
K843911 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 153d
Cleared Mar 05, 1985
PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU
K844135 · CHO
Immuno Nuclear Corp.
Chemistry · 133d
Cleared Mar 05, 1985
ELECTRONIC MUSCLE STIMULATOR
K844489 · IPF
Beverly Hills Exercise Equipment
Physical Medicine · 106d
Cleared Mar 05, 1985
ABSORBABLE GAUZE PRODUCTS
K844573 · EFQ
Medicon, Inc.
General & Plastic Surgery · 102d
Cleared Mar 05, 1985
TSH-STAT
K844583 · JLW
Nuclear Medical Laboratories, Inc.
Chemistry · 102d
Cleared Mar 05, 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · IPF
Excel Tech. , Ltd.
Physical Medicine · 98d
Cleared Mar 05, 1985
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 96d
Cleared Mar 05, 1985
ECHO TYPE 4 CF ANTIGEN
K844695 · GNL
Hillcrest Biologicals
Microbiology · 92d
Cleared Mar 05, 1985
TRI-COUNT CALIBRATOR
K844708 · KSA
Hematology Marketing Assoc.
Hematology · 92d
Cleared Mar 05, 1985
MODELS 134, 135 & 136 TRANSFER CART/TABLE
K844711 · INK
Tri W-G, Inc.
Physical Medicine · 92d
Cleared Mar 05, 1985
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
K844712 · INQ
Tri W-G, Inc.
Physical Medicine · 92d
Cleared Mar 05, 1985
NSI ELT-D DILUTING FLUID 4000ML
K844782 · GIF
Nobel Scientific Industries, Inc.
Hematology · 85d
Cleared Mar 05, 1985
ARTISAN FOLDING WHEELCHAIRS
K844799 · IOR
Artisan Wheel Chair Manufacturers
Physical Medicine · 84d