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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119497–119520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1991
BERMAN INTUBATING/PHARYNGEAL AIRWAY
K913680 · CAE
Chain Plastics Operations, Inc.
Anesthesiology · 52d
Cleared Oct 09, 1991
PEI PLAQUE ELECTRODE ARRAY
K904747 · DRF
Prucka Engineering, Inc.
Cardiovascular · 355d
Cleared Oct 09, 1991
HEMISPHERE MULTIPLANE ENDORECTAL PROBE
K911043 · ITX
Pie Medical Equipment B.V.
Radiology · 215d
Cleared Oct 09, 1991
PULPDENT POLYAMIDE DENTIN LINER
K911285 · EME
Pulpdent Corp.
Dental · 204d
Cleared Oct 09, 1991
HEMOCARD HEMOGLOBIN S
K911981 · GHM
Isolab, Inc.
Hematology · 159d
Cleared Oct 09, 1991
TRU-VIEW MULTI-CHANNEL DISPLAY
K912008 · DRT
General Devices
Cardiovascular · 156d
Cleared Oct 09, 1991
NOVOSTE VESSEL DILATER
K912050 · DRE
Novaste Corp.
Cardiovascular · 153d
Cleared Oct 09, 1991
BUTTERFLY DRESSING
K912160 · KGX
Durden Enterprises, Inc.
General & Plastic Surgery · 146d
Cleared Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
K912711 · GGP
Instrumentation Laboratory CO
Hematology · 112d
Cleared Oct 09, 1991
FIBRINOSTIKA FBDP MICROELISA SYSTEM
K912876 · DAP
Organon Teknika Corp.
Hematology · 100d
Cleared Oct 09, 1991
CCI VIDEOKERATOSCOPE/COMPARATOR
K913022 · HLQ
Cci
Ophthalmic · 92d
Cleared Oct 09, 1991
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 92d
Cleared Oct 09, 1991
FIBRINOGEN DETERMINATION KIT
K913061 · GIS
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Oct 09, 1991
FST CATH-UD CATHETER, MODIFICATION
K913113 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 96d
Cleared Oct 09, 1991
GLAUCOMA-SCOPE
K913118 · HLI
Ophthalmic Imaging Systems
Ophthalmic · 86d
Cleared Oct 09, 1991
A-DEC DECADE 1020 CHAIR
K913535 · KLC
A-Dec, Inc.
Dental · 61d
Cleared Oct 09, 1991
AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
K913572 · EMA
Specialites Septodont
Dental · 58d
Cleared Oct 09, 1991
ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL
K913698 · EBI
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Oct 09, 1991
MODERN MATERIALS ORTHODONTIC RESIN
K913699 · EBI
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Oct 09, 1991
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
K913705 · CFM
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Oct 09, 1991
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 47d
Cleared Oct 09, 1991
IMPERVA BOND
K913947 · EBF
Shofu Dental Corp.
Dental · 35d
Cleared Oct 09, 1991
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978 · CEK
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Oct 09, 1991
ICAN COTTON RAYON BALLS
K914081 · FRL
Icn Pharmaceuticals, Inc.
General Hospital · 28d