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
139897–139920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1987
(MSI) PATH-SAVER
K872140 · IFP
Medical Specialties, Inc.
Pathology · 13d
Cleared Jun 12, 1987
PULSE CUFF RECORDER MODEL PCR100
K863702 · JOM
Imex Medical Systems, Inc.
Cardiovascular · 262d
Cleared Jun 12, 1987
TATCH-IT
K870356 · DRS
Reunion Medical Co.
Cardiovascular · 134d
Cleared Jun 12, 1987
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 12, 1987
MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.
K871077 · GEI
Radionics, Inc.
General & Plastic Surgery · 86d
Cleared Jun 12, 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
K871152 · CIC
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Jun 12, 1987
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348 · LNK
Sharplan Lasers, Inc.
Gastroenterology & Urology · 67d
Cleared Jun 12, 1987
DIGITAL SPHYGMOMANOMETER
K871371 · DRS
Omron Tateisi Electronics Co.
Cardiovascular · 66d
Cleared Jun 12, 1987
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 59d
Cleared Jun 12, 1987
VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
K871487 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 58d
Cleared Jun 12, 1987
VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH
K871488 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 58d
Cleared Jun 12, 1987
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489 · DBF
Diagnostic Systems Laboratories, Inc.
Immunology · 58d
Cleared Jun 12, 1987
DELFIA(TM) HIGE KIT
K871599 · DHB
Lkb Instruments, Inc.
Immunology · 49d
Cleared Jun 12, 1987
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 49d
Cleared Jun 12, 1987
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
K871685 · JXG
American V. Mueller
Neurology · 44d
Cleared Jun 12, 1987
CARDIO-MEGA SYSTEM
K871890 · DSI
Grandcor Medical Systems
Cardiovascular · 28d
Cleared Jun 12, 1987
QM300 C3 ANTIBODY PACK
K871939 · CZW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 12, 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · CZP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 12, 1987
EYEDENTITY EYEWEAR
K872062 · HQZ
Vitech Research C/O Johnsen, Manfredi...
Ophthalmic · 15d
Cleared Jun 12, 1987
K-GEL
K872128 · KMJ
Taro Pharmaceuticals, Inc.
General Hospital · 10d
Cleared Jun 11, 1987
ENDOCATER
K863393 · LQY
The Hygenic Corp.
Dental · 281d
Cleared Jun 11, 1987
QUIK-BRUSH
K870414 · EFW
Intl. Medication Systems, Ltd.
Dental · 128d
Cleared Jun 11, 1987
4-9295 BARBITURATES TEST MIX
K871174 · DKB
Supelco, Inc.
Toxicology · 79d
Cleared Jun 11, 1987
LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
K871304 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 71d