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
96025–96048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1996
OSMED EPI-GUIDE
K940643 · LYC
Thm Biomedical, Inc.
Dental · 974d
Cleared Oct 15, 1996
IUP - TIP TRANS, IUP - PROXI TRANS
K961290 · KXO
Scientific Device Manufacturer, LLC
Obstetrics & Gynecology · 194d
Cleared Oct 15, 1996
MICROSPAN HYSTEROSCOPE
K961688 · HIH
Imagyn Medical, Inc.
Obstetrics & Gynecology · 167d
Cleared Oct 15, 1996
CHONDROPROTEC
K961930 · MGQ
The Hymed Group Corp.
General & Plastic Surgery · 151d
Cleared Oct 15, 1996
HEMOCUE B-GLCOSE SYSTEM
K962415 · LFR
Hemocue, Inc.
Chemistry · 125d
Cleared Oct 15, 1996
S-357 VIDEO IMAGING SYSTEM
K962684 · GCJ
Del Medical Systems Corp.
General & Plastic Surgery · 97d
Cleared Oct 15, 1996
HAEMOPHILUS TEST MEDIUM AGAR (HTM)
K962744 · JSO
Prepared Media Laboratory, Inc.
Microbiology · 92d
Cleared Oct 15, 1996
ECAT EXACT & ECAT EXACT HR+
K962797 · KPS
Cti Pet Systems, Inc.
Radiology · 89d
Cleared Oct 15, 1996
SPYGLASS ANGIOGRAPHIC CATHETER
K962805 · DQO
Daig Corp.
Cardiovascular · 89d
Cleared Oct 15, 1996
BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)
K963012 · LHI
Bioject, Inc.
General Hospital · 74d
Cleared Oct 15, 1996
CIBA CORNING ACS
K963251 · JMM
Ciba Corning Diagnostics Corp.
Chemistry · 57d
Cleared Oct 15, 1996
NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
K963266 · LPH
Intermedics Orthopedics
Orthopedic · 56d
Cleared Oct 15, 1996
SUPPORT VEST
K963459 · KID
Skil-Care Corp.
Physical Medicine · 42d
Cleared Oct 11, 1996
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
K953213 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 459d
Cleared Oct 11, 1996
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K954416 · LYY
Hartalega Sdn Bhd
General Hospital · 386d
Cleared Oct 11, 1996
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
K955712 · LDF
C.R. Bard, Inc.
Cardiovascular · 301d
Cleared Oct 11, 1996
FLOWTRON EXCEL PUMP
K961166 · JOW
Hne Healthcare, Inc.
Cardiovascular · 200d
Cleared Oct 11, 1996
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
K961368 · DPT
Vasamedics, LLC
Cardiovascular · 185d
Cleared Oct 11, 1996
OSOM STREP A TEST
K961423 · GTZ
Wyntek Diagnostics, Inc.
Microbiology · 182d
Cleared Oct 11, 1996
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
K962078 · JOH
Continental Medical Laboratories, Inc.
Anesthesiology · 136d
Cleared Oct 11, 1996
SAFETY CRADLE
K962149 · FMI
Specialized Health Products, Inc.
General Hospital · 129d
Cleared Oct 11, 1996
IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS
K962394 · DZE
Implant Integration Systems, Inc.
Dental · 113d
Cleared Oct 11, 1996
CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)
K962733 · EMA
Union Broach, Div. Moyco Industries,...
Dental · 88d
Cleared Oct 11, 1996
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · DYB
Cordis Corp.
Cardiovascular · 88d