Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
146137–146160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1986
CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM
K854745 · BTY
Versacor, Inc.
Anesthesiology · 45d
Cleared Jan 10, 1986
RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
K854880 · KPQ
Computerized Medical Systems, Inc.
Radiology · 35d
Cleared Jan 10, 1986
3M DRY SILVER IMAGER
K855043 · LMC
3M Company
Radiology · 24d
Cleared Jan 10, 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K855058 · JXG
Cordis Corp.
Neurology · 23d
Cleared Jan 10, 1986
NIR LAT MALE EXTERNAL CATHETER
K855209 · KNX
Mali, Inc.
Gastroenterology & Urology · 11d
Cleared Jan 10, 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 11d
Cleared Jan 10, 1986
KODAK RP X-OMAT PROCESSOR MODEL M6B
K855219 · IXW
Eastman Kodak Company
Radiology · 11d
Cleared Jan 10, 1986
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
K860023 · KDQ
Atrium Medical Corp.
General Hospital · 7d
Cleared Jan 09, 1986
TENS GB1001 DEVICE
K850855 · GZJ
Medicon, Inc.
Neurology · 314d
Cleared Jan 09, 1986
IMPLANTOFIX
K851293 · LJT
Burron Medical Products, Inc.
General Hospital · 283d
Cleared Jan 09, 1986
L-CATH EXPANDO CATH
K853348 · FOZ
Luther Medical Products, Inc.
General Hospital · 150d
Cleared Jan 09, 1986
IV MATE
K853843 · FLN
Medtech Intl., Inc.
General Hospital · 115d
Cleared Jan 09, 1986
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
K853875 · EWG
Endo Lase, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 09, 1986
ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
K853902 · EWG
Endo Lase, Inc.
Ear, Nose, Throat · 111d
Cleared Jan 09, 1986
I.V. DRESSING
K854040 · KMK
Consolidated Medical Equipment, Inc.
General Hospital · 99d
Cleared Jan 09, 1986
TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
K854446 · FPA
Terumo Medical Corp.
General Hospital · 65d
Cleared Jan 09, 1986
CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
K854562 · BRZ
Medelec Intl. Corp.
General Hospital · 56d
Cleared Jan 09, 1986
CHURCHILL-HCM VENTED IV SET
K854628 · FPA
Churchill Corp.
General Hospital · 52d
Cleared Jan 09, 1986
NORELCO DIGITAL THERMOMETER, MODEL HT 960
K854800 · FLL
Philips Park
General Hospital · 38d
Cleared Jan 09, 1986
ACUTE PERITONEAL DIALYSIS CATHETERS
K854966 · FKO
Thermedics, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K843189 · GQI
Labsystems, Inc.
Immunology · 513d
Cleared Jan 08, 1986
ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · NDC
Abbott Laboratories
Chemistry · 266d
Cleared Jan 08, 1986
EMERSON TRO/CATH TROCAR CATHETERS
K853132 · DRC
J. H. Emerson Co.
Cardiovascular · 166d
Cleared Jan 08, 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · FJG
Gambro, Inc.
Gastroenterology & Urology · 149d