FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89161–89184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222 · HWC
Synthes (Usa)
Orthopedic · 35d
Cleared Jul 29, 1998
LUNA
K982351 · OLT
Stellate Systems
Neurology · 23d
Cleared Jul 29, 1998
DOC VENTRAL CERVICAL STABILIZATION SYSTEM
K982443 · KWQ
Depuy Motech Acromed
Orthopedic · 15d
Cleared Jul 28, 1998
MODIFICATION TO THE OXYCONALPHA
K980094 · BTY
Erich Jaeger B.V.
Anesthesiology · 200d
Cleared Jul 28, 1998
MYO-TRAIN V (5)
K980158 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 193d
Cleared Jul 28, 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 85d
Cleared Jul 28, 1998
LIQUID A
K981618 · EMA
Harry J. Bosworth Co.
Dental · 83d
Cleared Jul 28, 1998
INFLUENCE CLIP SYSTEM
K981631 · FZP
Influence, Inc.
General & Plastic Surgery · 82d
Cleared Jul 28, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K981673 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K981674 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981675 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 77d
Cleared Jul 28, 1998
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
K981683 · FPA
Venusa , Ltd.
General Hospital · 76d
Cleared Jul 28, 1998
C0-AXIAL INTRODUCER NEEDLE
K981721 · KNW
Inrad
Gastroenterology & Urology · 74d
Cleared Jul 28, 1998
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
K981827 · FET
Angiolaz, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 28, 1998
UREA
K981918 · CDQ
Abbott Laboratories
Chemistry · 57d
Cleared Jul 28, 1998
CT 100 ELECTROCARDIOGRAPH
K981951 · DPS
Macquarie Medical Systems
Cardiovascular · 90d
Cleared Jul 27, 1998
MCS-MEDICATED CANAL SEALER
K973636 · EMA
Dr. Howard Martin, P.A.
Dental · 306d
Cleared Jul 27, 1998
PHOTON RADIOSURGERY SYSTEM PRS400
K980526 · JAD
Pec Photoelectron Corp.
Radiology · 167d
Cleared Jul 27, 1998
EUP-OL334 LAPARASCOPICPROBE
K981434 · ITX
Hitachi Medical Corp. of America
Radiology · 97d
Cleared Jul 27, 1998
MENISCAL REPAIR DEVICE
K981692 · MBI
Linvatec Corp.
Orthopedic · 75d
Cleared Jul 27, 1998
MPS RESERVOIR BAG
K982048 · KPE
Medical Product Specialists
General Hospital · 47d
Cleared Jul 26, 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · DRX
3M Healthcare
Cardiovascular · 243d
Cleared Jul 25, 1998
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
K982232 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 30d
Cleared Jul 24, 1998
RESOR-PIN RESORBABLE MEMBRANE PIN
K972817 · LYC
Geistlich-Pharma
Dental · 360d