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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97921–97944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1996
DDS SPINAL SYSTEM
K960107 · MNH
Encore Orthopedics, Inc.
Orthopedic · 113d
Cleared May 03, 1996
AS/3 COMPACT AIRWAY MODULE M-CAIOV
K960490 · CBS
Datex Medical Instrumentation, Inc.
Anesthesiology · 91d
Cleared May 03, 1996
CERCLAGE WIRE CRIMP BLOCK
K960651 · JDQ
Acu Med, Inc.
Orthopedic · 78d
Cleared May 03, 1996
AESOP SYSTEM AND ACCESSORIES
K960655 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 78d
Cleared May 03, 1996
BURCH/SCHNEIDER REINFORCEMENT CAGE
K960678 · JDI
Intermedics Orthopedics
Orthopedic · 77d
Cleared May 03, 1996
TANGENT VI TABLE
K961022 · IXR
Fischer Imaging Corp.
Radiology · 50d
Cleared May 03, 1996
BIO-DRESSING, STERILE ISLAND DRESSING
K961098 · MGP
K. W. Griffen Co.
General & Plastic Surgery · 45d
Cleared May 02, 1996
NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
K934695 · JWH
Intermedics Orthopedics
Orthopedic · 945d
Cleared May 02, 1996
KETOREX C SANWA
K953452 · JMK
Ihara Medics U.S., Inc.
Chemistry · 289d
Cleared May 02, 1996
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K954828 · CAH
Gibeck, Inc.
General Hospital · 195d
Cleared May 02, 1996
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
K955684 · DXT
Contour Fabricators of Florida, Inc.
Cardiovascular · 140d
Cleared May 02, 1996
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
K955707 · DHA
Excel Scientific, Inc.
Chemistry · 139d
Cleared May 02, 1996
22 MM COCR HEAD & POLYETHLENE LINER
K960180 · LPH
Stelkast Company
Orthopedic · 107d
Cleared May 02, 1996
ENA-C-T TOTAL CHOLESTEROL TEST
K960377 · CHH
Actimed Laboratories, Inc.
Chemistry · 97d
Cleared May 02, 1996
ABBOTT CELL-DYN 3500R SYSTEM
K960427 · GKZ
Sequoia Turner Corp.
Hematology · 94d
Cleared May 02, 1996
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP....
K960429 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 92d
Cleared May 02, 1996
TURBO TRACKER
K960806 · DQO
Target Therapeutics
Cardiovascular · 64d
Cleared May 02, 1996
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
K961293 · JJY
Consolidated Technologies, Inc.
Chemistry · 28d
Cleared May 01, 1996
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · FXX
3M Company
General Hospital · 159d
Cleared May 01, 1996
ACCUTEMP PROBE
K960080 · FMT
Kentec Medical, Inc.
General Hospital · 111d
Cleared May 01, 1996
MARTECH ENDOSCOPIC INJECTION NEEDLE
K960519 · FBK
Martech Medical Products, Inc.
Gastroenterology & Urology · 86d
Cleared May 01, 1996
MINISTICK PREGNANCY TEST
K960733 · LCX
Vanguard Biomedical Corp.
Chemistry · 69d
Cleared May 01, 1996
KARL STORZ URETER RESECTOSCOPE
K960757 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 68d
Cleared May 01, 1996
SERUM TOX CALIBRATOR
K961372 · DKB
Diagnostic Reagents, Inc.
Toxicology · 22d