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
116185–116208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1992
BARTELS LYME DISEASE IGM EIA
K922578 · LSR
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Sep 02, 1992
BARTELS TOXOPLASMA IGM EIA
K922579 · LGD
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Sep 02, 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · LGD
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Sep 02, 1992
LOW PROFILE TRACHEOSTOMY TUBE
K922749 · BTO
Concord/Portex
Anesthesiology · 86d
Cleared Sep 02, 1992
WOODBINE XT350, XENON ARC LIGHT SOURCE
K922820 · FST
Woodbine Ptical Corp.
General & Plastic Surgery · 83d
Cleared Sep 02, 1992
MODEL GT1ST CRYOSURGICAL INSTRUMENT
K922878 · GEH
Gyne-Tech Instrument Corp.
General & Plastic Surgery · 79d
Cleared Sep 02, 1992
TL100W/12
K922963 · FTC
Philips Lighting Co.
General & Plastic Surgery · 75d
Cleared Sep 02, 1992
TOTAL T3 CHEMILUMINESCENCE ASSAY
K923015 · CDP
Nichols Institute Diagnostics
Chemistry · 72d
Cleared Sep 02, 1992
THE NISSEL ARTIFICIAL EYE
K923167 · HQH
Nissel , Ltd.
Ophthalmic · 65d
Cleared Sep 01, 1992
CONTINUUM KNEE SYSTEM
K920080 · JWH
Techmedica, Inc.
Orthopedic · 237d
Cleared Sep 01, 1992
CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
K920846 · FXX
Trinity Laboratories, Inc.
General Hospital · 189d
Cleared Sep 01, 1992
LITE FIL II A
K920892 · EBF
Shofu Dental Corp.
Dental · 188d
Cleared Sep 01, 1992
LITE FILL II P
K920893 · EBF
Shofu Dental Corp.
Dental · 188d
Cleared Sep 01, 1992
STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT
K921010 · DZE
Apm Stern Gold
Dental · 182d
Cleared Sep 01, 1992
COMPOSITE RESIN CORE PASTE MATERIAL
K921174 · EBF
Centrix, Inc.
Dental · 174d
Cleared Sep 01, 1992
LUKENS 2-0 BRAIDED SILK SUTURES
K922254 · DQO
Quinton, Inc.
Cardiovascular · 203d
Cleared Sep 01, 1992
MEADOX SURGIMED BIOPSY GUN III
K922879 · KNW
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 78d
Cleared Sep 01, 1992
SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD
K923090 · JKA
Ryan Medical, Inc.
Chemistry · 68d
Cleared Sep 01, 1992
WALLSTENT ESOPHAGEAL PROTHESIS
K923119 · ESW
Schneider U.S. Stent Div.
Gastroenterology & Urology · 67d
Cleared Sep 01, 1992
MICROGUIDE LESION MARKING SYSTEM
K923120 · GDF
Angiodynamics, Div. E-Z-Em, Inc.
General & Plastic Surgery · 67d
Cleared Sep 01, 1992
DEROYAL EYE DRESSING
K923300 · KGX
Deroyal Industries, Inc.
General & Plastic Surgery · 57d
Cleared Sep 01, 1992
SHOWERFLOSS
K923457 · EFS
Summit Marketing Group, Inc.
Dental · 49d
Cleared Sep 01, 1992
LEOCOR CORFLO PUMP -- MODIFICATION
K924110 · DQI
Leocor, Inc.
General Hospital · 90d
Cleared Aug 31, 1992
OHMEDA MODEL 5250 RGM MONITOR
K920590 · CCK
Ohmeda Medical
Anesthesiology · 203d