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
149761–149784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1985
CMV TEST
K843138 · LIN
Microbiological Research Corp.
Microbiology · 173d
Cleared Jan 29, 1985
JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
K844093 · ESD
Jcm Labs, Inc.
Ear, Nose, Throat · 99d
Cleared Jan 29, 1985
PERRY SUTURING SET W/ANESTHETIC
K844610
Perry, Div.
Cardiovascular · 63d
Cleared Jan 29, 1985
WETS & DRIES
K844832
Abco Dealers, Inc.
General & Plastic Surgery · 48d
Cleared Jan 29, 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110 · CJE
Abbott Laboratories
Chemistry · 15d
Cleared Jan 28, 1985
KINAIR, LOW AIR LOSS BED
K843781 · FNL
Kinetic Concepts, Inc.
General Hospital · 124d
Cleared Jan 28, 1985
GRC-WT, GRC-W
K843899 · HKI
Olympus Corp.
Ophthalmic · 117d
Cleared Jan 28, 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP
K844627 · FRN
Strato Medical Corp.
General Hospital · 62d
Cleared Jan 28, 1985
MODEL 1001
K844718 · FRN
A0kfusion Systems, Inc.
General Hospital · 55d
Cleared Jan 28, 1985
360 INFUSER
K844719 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 55d
Cleared Jan 28, 1985
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
K844730 · FRN
C.R. Bard, Inc.
General Hospital · 55d
Cleared Jan 28, 1985
FLOW MED SK 140 BURET
K844820 · FPA
D.R.O. Medical, Inc.
General Hospital · 52d
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Jan 28, 1985
STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000
K845023 · LGX
Storz Instrument Co.
General Hospital · 32d
Cleared Jan 25, 1985
TRANSDUCER 4.OMHZ LA4011
K841048
Philips Ultrasound, Inc.
Radiology · 319d
Cleared Jan 25, 1985
THE BIBICURE SYS BREAST TONER
K843544 · HGY
Les Entreprises Bibi, Inc.
Obstetrics & Gynecology · 140d
Cleared Jan 25, 1985
ELEX ELECTRONIC DIGITAL THERMOMETER
K843609 · FLL
Ewing Intl. , Ltd.
General Hospital · 134d
Cleared Jan 25, 1985
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K844091 · FRN
Abbott Laboratories
General Hospital · 95d
Cleared Jan 25, 1985
K.M. PRODUCTS ASPIRATOR
K844200 · BTA
Km Products
General & Plastic Surgery · 87d
Cleared Jan 25, 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Jan 25, 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · FRN
Abbott Laboratories
General Hospital · 49d
Cleared Jan 25, 1985
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
K844879 · FNM
Huntleigh Technology, Inc.
General Hospital · 39d
Cleared Jan 25, 1985
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
K844880 · FNM
Huntleigh Technology, Inc.
General Hospital · 39d
Cleared Jan 25, 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · FPA
Y
General Hospital · 37d