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
158257–158280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1982
OXYGENATOR 10
K823343 · DTZ
Gambro, Inc.
Cardiovascular · 37d
Cleared Dec 15, 1982
COUNT-10 STAIN
K823363 · LEE
V-Tech, Inc.
Chemistry · 36d
Cleared Dec 15, 1982
COUNT-10 SYSTEM FOR STAND. URINALYSIS
K823364 · JQW
V-Tech, Inc.
Chemistry · 36d
Cleared Dec 15, 1982
ADVANCE EMIT(R) & TM AMIKACIN CONTROL
K823369 · LAS
Syva Co.
Toxicology · 35d
Cleared Dec 15, 1982
ALLERCOAT POSITIVE CONTROL SERUM
K823403 · DGC
Kallestad Laboratories, Inc.
Immunology · 30d
Cleared Dec 15, 1982
ARM BOARD W/I.V COVERING
K823412 · BTX
Sage Products, Inc.
General & Plastic Surgery · 30d
Cleared Dec 15, 1982
NEBULIZER CHRONOLOG & INTERPRETER
K823423 · CCQ
Advanced Technology Products, Inc.
Anesthesiology · 29d
Cleared Dec 15, 1982
ALLERCOAT ALLERGEN DISCS
K823470 · DHB
Kallestad Laboratories, Inc.
Immunology · 23d
Cleared Dec 15, 1982
MODUFLEX NEONATAL VENTILATOR SET
K823479 · BZO
Bd Becton Dickinson Vacutainer...
Anesthesiology · 22d
Cleared Dec 15, 1982
ENDODONTIC BROACH-BARBED BROACH
K823489 · EKW
Union Broach, Div. Moyco Industries,...
Dental · 22d
Cleared Dec 15, 1982
FULL-DISCLOSURE AMBULATORY ECG SYSTEM
K823529 · DPS
Clinical Data, Inc.
Cardiovascular · 22d
Cleared Dec 15, 1982
STIMUCORD EXTERNAL NEURAL STIM. 911A
K823530 · GZB
Cordis Corp.
Neurology · 16d
Cleared Dec 15, 1982
BEHIND-THE-EAR HEARING AID #8003
K823531 · ESD
Danavox, Inc.
Ear, Nose, Throat · 16d
Cleared Dec 15, 1982
STEREOMED CAMERA
K823534 · FTT
Diseases of the Skin Clinic, P.A.
General & Plastic Surgery · 25d
Cleared Dec 14, 1982
CARCINO-CEK
K823353 · JJX
Biologics Intl., Inc.
Immunology · 35d
Cleared Dec 14, 1982
MODEL 640 LINEAR SCANNER
K827176
Ge Medical Systems Information...
Radiology · 42d
Cleared Dec 14, 1982
ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCER
K828586
Cranbury Medical Labs, Inc.
Radiology · 21d
Cleared Dec 14, 1982
MAXICAMERA 300A SMALL FIELD OF VIEW IMAGING SYSTEM
K828595
General Electric Co.
Radiology · 49d
Cleared Dec 13, 1982
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K822681 · DHN
Amico Lab, Inc.
Microbiology · 101d
Cleared Dec 13, 1982
YSI MODEL 23L LACTATE ANALYZER
K822812 · HHP
Yellow Springs Instrument Co., Inc.
Chemistry · 84d
Cleared Dec 13, 1982
UROCOMP REMOTE CONTROL 1804
K822916 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 73d
Cleared Dec 13, 1982
MINISTIM 180
K822924 · IPF
Micron Instruments, Inc.
Physical Medicine · 73d
Cleared Dec 13, 1982
THE PROGRESSIVE CHAIR
K823277 · INN
Progressive Productions , Ltd.
Physical Medicine · 40d
Cleared Dec 09, 1982
AIRWAY TEMPERATURE SENSOR
K821505 · GEI
Mon-A-Therm, Inc.
General & Plastic Surgery · 203d