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
124561–124584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1990
LAPAROSCOPE
K903528 · HET
Intramed Laboratories, Inc.
Obstetrics & Gynecology · 29d
Cleared Sep 04, 1990
PUCK 90M
K903576 · KPX
Elema-Schonander, Inc.
Radiology · 27d
Cleared Sep 04, 1990
MODEL 610 MODIFIED
K903657 · LDD
First Medical Devices Corp.
Cardiovascular · 26d
Cleared Sep 04, 1990
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
K903699 · JOH
Passy & Passy, Inc.
Anesthesiology · 20d
Cleared Sep 04, 1990
AVI MICRO 285CM INFUSION PUMP
K903788 · FRN
3M Avi, Inc.
General Hospital · 15d
Cleared Sep 04, 1990
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · BSJ
Ventlab Corp.
Anesthesiology · 13d
Cleared Aug 31, 1990
PIEZON MASTER 400
K896749 · ELC
Electro Medical Systems (Ems Sa)
Dental · 274d
Cleared Aug 31, 1990
SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND
K900683 · ITX
Hitachi Medical Corp. of America
Radiology · 199d
Cleared Aug 31, 1990
F-20 CEMENTED METAL-BACKED ACETABULAR CUP
K901451 · JDI
Med-Tek Corp.
Orthopedic · 151d
Cleared Aug 31, 1990
CHALLENGE 7010 POWERED MUSCLE STIMULATOR
K902511 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
CHALLENGE 8000 POWERED MUSCLE STIMULATOR
K902512 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
CHALLENGE 6010 POWERED MUSCLE STIMULATOR
K902513 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
CHALLENGE 5010 POWERED MUSCLE STIMULATOR
K902514 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP
K903411 · CAW
Guild Assoc., Inc.
Anesthesiology · 32d
Cleared Aug 31, 1990
CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
K903544 · LRP
J.J. Skinner, Inc.
General & Plastic Surgery · 25d
Cleared Aug 30, 1990
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795 · KGI
Hologic, Inc.
Radiology · 406d
Cleared Aug 30, 1990
ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.
K896134 · GCX
Goosen Enterprises, Inc.
General Hospital · 310d
Cleared Aug 30, 1990
PERLINK SCREEN, KIRAN SCREEN
K896707 · EAM
Perlink USA, Inc.
Radiology · 275d
Cleared Aug 30, 1990
GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
K896757 · FKP
Gambro, Inc.
Gastroenterology & Urology · 272d
Cleared Aug 30, 1990
THE MONITOR ELECTRONIC BED ALARM SYSTEM
K901330 · KMI
The Monitor Corp.
General Hospital · 161d
Cleared Aug 30, 1990
CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
K902444 · DQI
Intramed Laboratories, Inc.
General Hospital · 90d
Cleared Aug 30, 1990
CATHSCANNER(R) PTA BALLOON DILATATION CATHETER
K902454 · LIT
Endosonics Corp.
Cardiovascular · 90d
Cleared Aug 30, 1990
CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY
K902464 · KPE
Chartermed, Inc.
General Hospital · 87d
Cleared Aug 30, 1990
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · FLL
Bd Becton Dickinson Vacutainer...
General Hospital · 77d