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
108985–109008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1994
SLIT LAMP, H-201
K936209 · HJO
Canon USA, Inc.
Ophthalmic · 93d
Cleared Apr 01, 1994
OTOSONIC (OSI) LPS D
K940099 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
PROFILE IC
K940100 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC ACS II D WITH SRR
K940101 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
BELTONE OPERA/OPERA MHP/OPERA MAX
K940102 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
BELTONE ODE AND BELTONE ODE VX
K940103 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
K940177 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 80d
Cleared Apr 01, 1994
NEUROMUSCULAR ELECTRICAL STIMULATOR
K940349 · IPF
Progressive Concepts, Inc.
Physical Medicine · 66d
Cleared Mar 31, 1994
PHARMETRIX MINIPUMP MODEL 5120
K924603 · FRN
Pharmetrix, Inc.
General Hospital · 566d
Cleared Mar 31, 1994
CERAMCO CROWNS AND BRIDGES
K926165 · EJH
Asap Dental Lab, Ltd.
Dental · 478d
Cleared Mar 31, 1994
PEGASUS PROACTIVE WHEELCHAIR CUSHION
K930742 · ITI
Pegasus Airwave, Inc.
Physical Medicine · 412d
Cleared Mar 31, 1994
PISTOL SUCTION/IRRIGATION PROBE
K930813 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 407d
Cleared Mar 31, 1994
OLYMPUS SUCTION PUMP MODEL KV-4
K930852 · JCX
Keymed (Medical & Industrial...
General & Plastic Surgery · 406d
Cleared Mar 31, 1994
ARTHOSCOPE AND ACCESSORIES
K931076 · HRX
Meditron Devices, Inc.
Orthopedic · 394d
Cleared Mar 31, 1994
SPECTROPAD SYSTEM
K931261 · ILY
Smi
Physical Medicine · 384d
Cleared Mar 31, 1994
MEDIPAK AMBULATORY INFUSION PUMP
K931458 · FRN
Medication Delivery Devices, Inc.
General Hospital · 373d
Cleared Mar 31, 1994
MODEL 151 FETAL MONITOR
K932077 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 336d
Cleared Mar 31, 1994
SMARTSCOPE
K932533 · JXE
Insight Medical Corp.
Neurology · 309d
Cleared Mar 31, 1994
RIVER PUMP
K932895 · FRN
River Medical, Inc.
General Hospital · 290d
Cleared Mar 31, 1994
SKIN BIOPSY DEVICE
K933324 · MJG
Nhr, Inc.
General & Plastic Surgery · 262d
Cleared Mar 31, 1994
ULTRACAM
K933671 · EIA
Dental Vision Direct, Inc.
Dental · 246d
Cleared Mar 31, 1994
HBM HEMOGLOBINOMETER
K933836 · GIG
Artel, Inc.
Hematology · 238d
Cleared Mar 31, 1994
HEP-2 CULTURE CELL
K933927 · KIR
Neogenex
Pathology · 233d
Cleared Mar 31, 1994
MENLO CARE URINARY DIVERSION STENT
K933941 · FAD
Menlo Care, Inc.
Gastroenterology & Urology · 231d