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
170377–170400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1978
TINNITUS MASKER
K781798 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 11d
Cleared Nov 03, 1978
MAXI-CHAIR
K781801 · HME
Surgical Mechanical Research, Inc.
Ophthalmic · 11d
Cleared Nov 03, 1978
RECORDER, HOLTER ELECTROCARDIOGRAM
K781843 · DSH
Hovik Corp.
Cardiovascular · 2d
Cleared Nov 03, 1978
LATEX, IN-HOUSE COMPOUNDED
K781847 · KGO
Arbrook Mfg. Corp.
General Hospital · 1d
Cleared Nov 01, 1978
LUBE-LOK
K781695 · CBH
Olympic Medical Corp.
Anesthesiology · 22d
Cleared Oct 31, 1978
PREGELLED DISPOSABLE E.K.G. ELECTRODE
K781430 · DRX
Vermont Medical, Inc.
Cardiovascular · 71d
Cleared Oct 31, 1978
EEG LEAD ASSEMBLY
K781494 · GXY
Graphic Controls Corp.
Neurology · 64d
Cleared Oct 31, 1978
MISTY-OX PREFILLED HUMIDIFIER, DISP.
K781600 · BTT
Davco
Anesthesiology · 43d
Cleared Oct 30, 1978
VARIABLE STIFFNESS WIRE GUIDE
K781393 · DQX
Cook, Inc.
Cardiovascular · 81d
Cleared Oct 27, 1978
STRAIN GAUGE PLETHYSMOGRAPH
K781352 · DSB
Medimatic
Cardiovascular · 81d
Cleared Oct 27, 1978
CASTLE MODEL 3146 GAS AERATOR
K781484 · FLI
Castle Co.
General Hospital · 60d
Cleared Oct 27, 1978
HEMO-W SYSTEM
K781628 · GKL
Coulter Electronics, Inc.
Hematology · 32d
Cleared Oct 27, 1978
SERI-SEP SERUM/PLASMA ISLOLATOR
K781629 · JKA
Wako Intl., Inc.
Chemistry · 32d
Cleared Oct 27, 1978
AUTODILUTER 2
K781645 · JQW
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Oct 27, 1978
SRD-2
K781646 · JQW
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Oct 27, 1978
RIA KIT, LH
K781685 · CEP
Amersham Corp.
Chemistry · 23d
Cleared Oct 27, 1978
L-CYSTEINE HYDROCHLORIDE
K781690 · JHS
Fisher Scientific Co., LLC
Chemistry · 23d
Cleared Oct 27, 1978
PRESSURE, LOW/HIGH MODEL C1070
K781697 · CAP
Timeter Instrument Corp.
Anesthesiology · 17d
Cleared Oct 27, 1978
MONITOR, GRAVITY IRRIGATION DRIP
K781717 · FLN
Syntel, Inc.
General Hospital · 16d
Cleared Oct 27, 1978
KENDRICK EXTRICATION DEVICE
K781761 · IQF
Medi-Ked, Inc.
Physical Medicine · 11d
Cleared Oct 27, 1978
PACING LEADS MODEL UL-811 AND UL-813
K781776 · DTB
Pacesetter Systems
Cardiovascular · 14d
Cleared Oct 26, 1978
TRAUMA DRAINAGE SET 72T-28TTC
K781550 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
TRAUMA DRAINAGE SET 72T-32TTC
K781551 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2
K781552 · CAC
Sorensen Research
Anesthesiology · 44d