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
141649–141672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1986
CANDELA MODEL SPT-1, PULSED DYE LASER
K861179 · GEX
Candela Corp.
General & Plastic Surgery · 234d
Cleared Nov 20, 1986
CASE 12
K862316 · DSI
Marquette Electronics, Inc.
Cardiovascular · 155d
Cleared Nov 20, 1986
630C ELECTROCARDIOGRAPH
K863030 · DPS
Quinton, Inc.
Cardiovascular · 101d
Cleared Nov 20, 1986
TERUMO RADIFOCUS GUIDE WIRE
K863138 · DQX
Terumo Medical Corp.
Cardiovascular · 97d
Cleared Nov 20, 1986
CLAMPEASE FA
K863427 · DXC
Freund Medical Products
Cardiovascular · 77d
Cleared Nov 20, 1986
CHIN-FOGARTY INFLATION DEVICE
K863596 · DXT
American Edwards Laboratories
Cardiovascular · 66d
Cleared Nov 20, 1986
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724 · DSI
Oxford Medilog, Inc.
Cardiovascular · 58d
Cleared Nov 20, 1986
EM III DISPOSABLE ELECTRODE
K863845 · DRX
Electromed Intl., Ltd.
Cardiovascular · 50d
Cleared Nov 20, 1986
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
K864002 · DTB
Intermedics, Inc.
Cardiovascular · 37d
Cleared Nov 20, 1986
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
K864155 · DTJ
American Edwards Laboratories
Cardiovascular · 28d
Cleared Nov 20, 1986
HALL DUNBAR DRILL GUIDE SYSTEM
K864163 · HRX
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 28d
Cleared Nov 20, 1986
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
K864287 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 19, 1986
CATHETER VALVES KV 100 & KV 100EH
K861699 · KOD
Max Staubli , Ltd.
Gastroenterology & Urology · 198d
Cleared Nov 19, 1986
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
K862598 · LNK
Laserscope
Gastroenterology & Urology · 141d
Cleared Nov 19, 1986
ZINETICS GASTROMETER (TM)
K862727 · FFT
Zinetics Medical Technology Corp.
Gastroenterology & Urology · 124d
Cleared Nov 19, 1986
MALE URINARY STRESS PAD*
K862877 · EYQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 112d
Cleared Nov 19, 1986
FREE & ACTIVE(TM) ABSORBENT PADS
K862878 · EYQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 112d
Cleared Nov 19, 1986
MENTOR ALLOPLASTIC SPERMATOCELE
K863565 · LQS
Mentor Corp.
Gastroenterology & Urology · 68d
Cleared Nov 19, 1986
P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG
K863854
Precision Medical Devices, Inc.
Orthopedic · 48d
Cleared Nov 19, 1986
AUSTIN MOORE HIP PROSTHESIS
K863896
Kirschner Medical Corp.
Orthopedic · 43d
Cleared Nov 19, 1986
DENTAL PROPHY CUPS (VARIOUS TYPES)
K864059 · EHK
Mission White Dental, Inc.
Dental · 30d
Cleared Nov 19, 1986
SR-MODEL 230 (MODIFICATION)
K864106 · FRN
Hirata Sangyo Co. USA, Inc.
General Hospital · 29d
Cleared Nov 19, 1986
SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T
K864195 · FLL
Respiratory Support Products, Inc.
General Hospital · 23d
Cleared Nov 19, 1986
DR.500O OPERATING TABLE
K864295 · FQO
Koken Mfg Company, Inc.
General & Plastic Surgery · 19d