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
108049–108072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1994
DMI UTERINE MOBILIZER/ELEVATOR/CANNULA
K931814 · LKF
Diversified Medical Instruments, Inc.
Obstetrics & Gynecology · 418d
Cleared May 31, 1994
TRANSIT INFUSION CATHETER
K936260 · DQO
Cordis Corp.
Cardiovascular · 152d
Cleared May 31, 1994
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K940607 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 110d
Cleared May 31, 1994
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K940636 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 106d
Cleared May 31, 1994
NOVAGEL SILICONE GEL SHEETING
K941125 · MDA
Brennen Medical, Inc.
General & Plastic Surgery · 83d
Cleared May 31, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
K941485 · DQX
Cardio Metrics, Inc.
Cardiovascular · 64d
Cleared May 27, 1994
NEBULIZER PUMP, POWERED, MODEL 1110
K925010 · BTI
Thomas Industries
Anesthesiology · 602d
Cleared May 27, 1994
MODEL 80-1983, ELECTROSURGICAL GENERATOR
K931437 · HGI
Cameron-Miller, Inc.
Obstetrics & Gynecology · 431d
Cleared May 27, 1994
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
K931444 · DTZ
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 431d
Cleared May 27, 1994
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM
K932123 · DZE
Implant Innovations International, Inc.
Dental · 389d
Cleared May 27, 1994
SLT FEMORAL HEAD
K932222 · LZO
Dow Corning Wright
Orthopedic · 385d
Cleared May 27, 1994
TEN-20 CONDUCTIVE PASTE GEL
K933799 · GYB
Cadwell Laboratories, Inc.
Neurology · 296d
Cleared May 27, 1994
ABL SYSTEM 620
K935121 · CHL
Radiometer America, Inc.
Chemistry · 212d
Cleared May 27, 1994
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
K935434 · LKF
United States Surgical, A Division of...
Obstetrics & Gynecology · 198d
Cleared May 27, 1994
ABL5 BLOOD GAS SYSTEM
K935655 · CHL
Radiometer America, Inc.
Chemistry · 184d
Cleared May 27, 1994
SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)
K936038 · FJL
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 158d
Cleared May 27, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K940159 · JXM
Microgenics Corp.
Toxicology · 135d
Cleared May 27, 1994
TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
K940160 · ILO
Burke Neutech, Inc.
Physical Medicine · 135d
Cleared May 27, 1994
REBREATHER BAGS
K940220 · BTC
Zefon Medical Products
Anesthesiology · 126d
Cleared May 27, 1994
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY...
K940422 · DFZ
The Binding Site, Ltd.
Immunology · 128d
Cleared May 27, 1994
CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
K940860 · ELW
Ultradent Products, Inc.
Dental · 93d
Cleared May 27, 1994
MODIFIED ENDOPATH ILS
K940967 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 86d
Cleared May 27, 1994
UNKNOWN
K941032 · FMF
Gelman Sciences, Inc.
General Hospital · 81d
Cleared May 27, 1994
ULTRAFREE-CL
K941326 · JJH
Millipore Corp.
Chemistry · 70d