FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129433–129456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1989
FORTRESS 655FS POWER WHEELCHAIR
K895595 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 20d
Cleared Oct 05, 1989
FORTRESS 2000FS 3-WHEEL SCOOTER
K895693 · INI
Fortress Scientific , Ltd.
Physical Medicine · 13d
Cleared Oct 05, 1989
SHARPLAN MODEL 710 MICROSPOT
K895746 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 9d
Cleared Oct 04, 1989
GIPHY MONITOR
K883960 · FFT
Vascular Technology Incorporated
Gastroenterology & Urology · 379d
Cleared Oct 04, 1989
DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER
K884915 · FAP
Dantec Electronics, Inc.
Gastroenterology & Urology · 310d
Cleared Oct 04, 1989
TARGET OPIATES-V
K890979 · DJG
V-Tech, Inc.
Toxicology · 219d
Cleared Oct 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892608 · LYY
Grand Design Sdn. Bhd.
General Hospital · 177d
Cleared Oct 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892609 · LYY
Commfields (M) Sdn. Bhd.
General Hospital · 177d
Cleared Oct 04, 1989
PRO-JECT(TM) SAFETY NEEDLE HOLDER
K892665 · JKA
Pro-Tec Containers, Inc.
Chemistry · 174d
Cleared Oct 04, 1989
PATIENT EXAMINATION GLOVES
K892996 · LYY
Multiplus Trading , Ltd.
General Hospital · 175d
Cleared Oct 04, 1989
PATIENT EXAMINATION GLOVES
K892998 · LYY
Shen Yunn Plastics Corp.
General Hospital · 175d
Cleared Oct 04, 1989
CALCIUM (ARSENAZO III) REAGENT
K894204 · CJY
Sigma Diagnostics, Inc.
Chemistry · 107d
Cleared Oct 04, 1989
MODEL 480 INFUSION PUMP
K894320 · FRN
3M Company
General Hospital · 82d
Cleared Oct 04, 1989
OSSEODENT SURGICAL KIT
K894331 · DZE
Collagen Corp.
Dental · 82d
Cleared Oct 04, 1989
MODEL 280 INFUSION PUMP
K894360 · FRN
3M Company
General Hospital · 82d
Cleared Oct 04, 1989
ORTHO RESULT PLUS/PREGNANCY
K894420 · JHI
Ortho Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Oct 04, 1989
WOLDOFF PRISMATIC BICONCAVE LENS
K894421 · HJK
Ocular Instruments, Inc.
Ophthalmic · 79d
Cleared Oct 04, 1989
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K894575 · CDX
Technicon Instruments Corp.
Chemistry · 75d
Cleared Oct 04, 1989
MASCOT EXAMINATION GLOVES
K894587 · LYY
Mascot, Inc.
General Hospital · 72d
Cleared Oct 04, 1989
LATEX EXAMINATION GLOVES
K894677 · LYY
Kumpulan Santra (Penang) Sdn. Bhd.
General Hospital · 72d
Cleared Oct 04, 1989
NIDEK MODEL ADC-8000
K894709 · GEX
Nidek, Inc.
General & Plastic Surgery · 72d
Cleared Oct 04, 1989
DELFIA PLATE FLUOROMETER 1232
K895240 · KHO
Pharmacia, Inc.
Chemistry · 44d
Cleared Oct 04, 1989
LATEX EXAMINATION GLOVES
K895332 · LYY
Ever Glory Intl., Inc.
General Hospital · 34d
Cleared Oct 04, 1989
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
K895339 · LLL
Immco Diagnostics, Inc.
Immunology · 34d