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
89281–89304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1998
AURORA DIODE LASER SYSTEM
K974586 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 218d
Cleared Jul 15, 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
K974736 · DWF
Heartport, Inc.
Cardiovascular · 208d
Cleared Jul 15, 1998
OCULOSTAT
K981235 · HNC
Laser Center Dev. Corp.
Ophthalmic · 103d
Cleared Jul 15, 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT...
K981381 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Jul 15, 1998
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
K981533 · DRG
American Telecare, Inc.
Cardiovascular · 77d
Cleared Jul 15, 1998
NTI CLENCHING SUPPRESSION SYSTEM
K981546 · MQC
Heraeus Kulzer, Inc.
Dental · 76d
Cleared Jul 15, 1998
TYMPANOSTOMY TUBE
K981575 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared Jul 15, 1998
VACUETTE MULTIPLE SAMPLE LUER ADAPTER
K981619 · FMI
Greiner Meditech, Inc.
General Hospital · 70d
Cleared Jul 14, 1998
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
K974040 · FHA
Timm Research Co.
Gastroenterology & Urology · 263d
Cleared Jul 14, 1998
SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING...
K974457 · IYO
Hewlett-Packard Co.
Radiology · 231d
Cleared Jul 14, 1998
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS...
K974730 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 208d
Cleared Jul 14, 1998
AUTO-INJECTOR, SURE-INJECT 2000
K981266 · KZH
Mighty Mo, Corp.
General Hospital · 98d
Cleared Jul 14, 1998
PAR-ONE
K981391 · LIO
Remel, Inc.
Microbiology · 88d
Cleared Jul 14, 1998
0-20 CM H20 PEEP VALVE
K981415 · BYE
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 85d
Cleared Jul 14, 1998
MEMBRANE TACK
K981459 · DZL
Biomet, Inc.
Dental · 82d
Cleared Jul 14, 1998
XR-910
K981466 · IZL
Imaging Sciences Intl., Inc.
Radiology · 82d
Cleared Jul 14, 1998
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
K981475 · LNH
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Jul 14, 1998
CARESIDE HDL-CHOLESTEROL
K981899 · LBS
Exigent Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 14, 1998
FLUOROSPOT COMPACT
K982028 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Jul 14, 1998
BIOPSY M
K982049 · IZH
Sitco, Inc.
Radiology · 33d
Cleared Jul 14, 1998
CAAS II LVA BIPLANE OPTION
K982203 · IZI
Pie Medical Equipment B.V.
Radiology · 22d
Cleared Jul 14, 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · CEC
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jul 13, 1998
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K972401 · KRO
Howmedica Corp.
Orthopedic · 382d
Cleared Jul 13, 1998
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
K980040 · IPF
Nisha Communication Industries
Physical Medicine · 189d