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
128833–128856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1989
THE ORIGINAL PULSE-PAK
K892639 · NFB
Jones Sales Co.
Anesthesiology · 176d
Cleared Oct 05, 1989
BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
K892841 · CCJ
Bedfont Technical Instruments , Ltd.
Anesthesiology · 170d
Cleared Oct 05, 1989
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · HIR
Bivona Medical Technologies
Gastroenterology & Urology · 168d
Cleared Oct 05, 1989
MODEL 285 INFUSION PUMP
K894321 · FRN
3M Company
General Hospital · 83d
Cleared Oct 05, 1989
LIFECARE PRESSURE ALARM CAT. NO. 34-010
K894361 · CAP
Lifecare Services, Inc.
Anesthesiology · 83d
Cleared Oct 05, 1989
LATEX PATIENT EXAMINATION GLOVES
K894453 · LYY
Mittal Meditex Pvt. , Ltd.
General Hospital · 107d
Cleared Oct 05, 1989
GYNECOLOGIC EXAMINATION KIT
K894489 · HIB
A & A Medical, Inc.
Obstetrics & Gynecology · 77d
Cleared Oct 05, 1989
STERILE ULTRASOUND TRANSMISSION GEL
K894490 · JOT
Swedish Trade Council USA
General & Plastic Surgery · 79d
Cleared Oct 05, 1989
SIEMENS ENDO-P-PROBE
K894806 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Oct 05, 1989
IRIS OCULIGHT(TM) SL
K894841 · GEX
Iriderm Div.
General & Plastic Surgery · 66d
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