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
140809–140832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1987
PROPHY CARE SOLUTION
K865082 · EJR
Imd, Inc.
Dental · 44d
Cleared Feb 12, 1987
IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM
K870039 · DSF
Par Microsystems Corp.
Cardiovascular · 38d
Cleared Feb 12, 1987
ASPIRATION REVERSAL CONTROL (ARC) MODULE
K870068 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 35d
Cleared Feb 12, 1987
SUMMIT OPTICS CONTACT LENS REMOVER
K870072 · KYE
Dayton Mfg. Co.
Ophthalmic · 35d
Cleared Feb 12, 1987
STORZ ENT/OPHTHALMIC MAXI CHAIR
K870112 · HME
Storz Instrument Co.
Ophthalmic · 31d
Cleared Feb 12, 1987
ALLERGEN SPECIFIC IGG4 CONTROL SERA
K870153 · DHB
3M Company
Immunology · 30d
Cleared Feb 12, 1987
KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5
K870203 · HKK
Keeler Instruments, Inc.
Ophthalmic · 23d
Cleared Feb 12, 1987
THERMOMETER SHEATHES, STERILE (GLASS)
K870285 · FLK
The Medical Group, Inc.
General Hospital · 16d
Cleared Feb 11, 1987
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
K861988 · JDI
Protek, Inc.
Orthopedic · 278d
Cleared Feb 11, 1987
WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET
K864364 · KNT
Technical Associates of New England
Gastroenterology & Urology · 98d
Cleared Feb 11, 1987
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P1
K864739 · LLZ
Eastman Kodak Company
Radiology · 69d
Cleared Feb 11, 1987
TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
K864835 · FCD
Eisai U.S.A., Inc.
Radiology · 64d
Cleared Feb 11, 1987
KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10
K864927 · LLZ
Eastman Kodak Company
Radiology · 69d
Cleared Feb 11, 1987
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
K865076 · JHI
Syntron Bioresearch, Inc.
Chemistry · 44d
Cleared Feb 11, 1987
MOBIL-AIR
K870064 · CAW
Roman Laboratories, Inc.
Anesthesiology · 71d
Cleared Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · JIF
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Feb 11, 1987
EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)
K870429 · JAA
The Mason Clinic
Radiology · 6d
Cleared Feb 10, 1987
OSTEO TITANIUM DENTAL IMPLANT
K862854 · DZE
Osteo Implant Corp.
Dental · 196d
Cleared Feb 10, 1987
BIRD 6400ST VOLUME VENTILATOR
K863228 · CBK
Bird Products Corp.
Anesthesiology · 173d
Cleared Feb 10, 1987
DATASCOPE BALLOON DILATATION CATHETER
K863608
Datascope Corp.
Cardiovascular · 147d
Cleared Feb 10, 1987
RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE
K863700 · ITX
General Electric Co.
Radiology · 140d
Cleared Feb 10, 1987
TAMPER HAMPER
K863872 · LPZ
Hydro-Med Products, Inc.
General Hospital · 130d
Cleared Feb 10, 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · DXY
Ela Medical, Inc.
Cardiovascular · 126d