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
90769–90792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1998
IMAGEACCESS SYSTEM
K973805 · LMD
Storcomm, Inc.
Radiology · 88d
Cleared Jan 02, 1998
FOUNDATION FRACTURE STEM
K973809 · JDI
Encore Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 02, 1998
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR
K973863 · DXH
Hi-Tronics Designs, Inc.
Cardiovascular · 85d
Cleared Jan 02, 1998
UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE
K973890 · GEI
Conmedcorp
General & Plastic Surgery · 80d
Cleared Jan 02, 1998
AIMSTICK PBD PREGNANCY
K974368 · DHA
Germaine Laboratories, Inc.
Chemistry · 43d
Cleared Jan 02, 1998
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · JKA
Ohmeda Medical
Chemistry · 43d
Cleared Jan 02, 1998
AIMSTICK PBD COMBO PREGNANCY
K974512 · DHA
Germaine Laboratories, Inc.
Chemistry · 32d
Cleared Jan 02, 1998
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K974620 · JIF
Trace America, Inc.
Chemistry · 22d
Cleared Jan 02, 1998
IMMULITE FREE T3
K974634 · CDP
Diagnostic Products Corp.
Chemistry · 21d
Cleared Dec 31, 1997
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 31, 1997
TEMPERATURE DIAGNOSTIC ACCESSORY
K973764 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Dec 30, 1997
EVERYTIME TRANSFUCER COVER
K955893 · ITX
Amedic AB
Radiology · 746d
Cleared Dec 30, 1997
WELLCOLEX E.COLI O157:H7
K971663 · GMZ
Murex Biotech , Ltd.
Microbiology · 238d
Cleared Dec 30, 1997
SENTINEL RECORDER, MODELS 471/472
K971696 · DXH
Del Mar Avionics
Cardiovascular · 236d
Cleared Dec 30, 1997
MEDRAD 1.5T EXTREMITY ARRAY
K973787 · MOS
Medrad, Inc.
Radiology · 85d
Cleared Dec 30, 1997
CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING...
K973833 · IZL
Dynarad Corp.
Radiology · 84d
Cleared Dec 29, 1997
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
K971570 · DRR
Quinton Electrophysiology Corp.
Cardiovascular · 244d
Cleared Dec 29, 1997
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
K971775 · LDF
Cardiac Control Systems, Inc.
Cardiovascular · 230d
Cleared Dec 29, 1997
HI-CARE CLOSED SUCTION SYSTEM
K972258 · BSY
Mallinckrodt Medical
Anesthesiology · 195d
Cleared Dec 29, 1997
AESCULAP HILAN MOTOR SYSTEM
K973736 · HWE
Aesculap, Inc.
Orthopedic · 89d
Cleared Dec 29, 1997
UNICATH SP BI-PLANE (MODEL M269 & M289)
K973744 · JAA
Xre Corp.
Radiology · 89d
Cleared Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 87d
Cleared Dec 29, 1997
DUODERM HYDROACTIVE GEL
K973806 · MGQ
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 84d
Cleared Dec 29, 1997
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
K973857 · JAF
Biomedix, Inc.
Radiology · 81d