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
93793–93816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1997
RAICHEM RHEUMATOID FACTOR SPIA
K970373 · DHR
Henage Diagnostics, Inc.
Immunology · 73d
Cleared Apr 17, 1997
VS-100 VIDEO SIGMOIDOSCOPE
K970382 · FAM
Welch Allyn, Inc.
Gastroenterology & Urology · 73d
Cleared Apr 17, 1997
SASI-DC1TS
K970580 · KDW
Substance Abuse Specialties, Inc.
Chemistry · 62d
Cleared Apr 17, 1997
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
K970778 · JJX
More Diagnostics
Chemistry · 44d
Cleared Apr 17, 1997
GRAM SWAB
K970834 · JTO
Remel, Inc.
Microbiology · 41d
Cleared Apr 17, 1997
CHASE SUCKER
K971022 · GCX
Chase Medical, Inc.
General Hospital · 28d
Cleared Apr 17, 1997
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · LAS
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Apr 16, 1997
MINIMATIC VARIOUS IMPLANT SYSTEMS
K952905 · DZE
Minimatic, Inc.
Dental · 664d
Cleared Apr 16, 1997
SINUSCAN 102/SINUSPRINT
K960421 · LWI
Ferguson Medical
Radiology · 443d
Cleared Apr 16, 1997
STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
K963646 · GEI
Stryker Endoscopy
General & Plastic Surgery · 216d
Cleared Apr 16, 1997
OPTIVENT
K963793 · CAF
Health Care Products, Inc.
Anesthesiology · 205d
Cleared Apr 16, 1997
BARD AND BTA TEST
K964151 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 197d
Cleared Apr 16, 1997
CHASE AORTIC ARCH CANNULA
K964193 · DWF
Chase Medical, Inc.
Cardiovascular · 177d
Cleared Apr 16, 1997
CHASE CURVED LEFT HEART VENT CATHETER
K964194 · DWF
Chase Medical, Inc.
Cardiovascular · 177d
Cleared Apr 16, 1997
CHASE MULTIPLE PERFUSION SET
K964200 · DWF
Chase Medical, Inc.
Cardiovascular · 177d
Cleared Apr 16, 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307 · KGI
Lunar Corp.
Radiology · 169d
Cleared Apr 16, 1997
PICC CATHETER/MIDLINE CATHETER
K964447 · LJS
Menlo Care, Inc.
General Hospital · 161d
Cleared Apr 16, 1997
HR POLYURETHANE PICC AND MIDLINE CATHETERS
K964556 · LJS
Johnson & Johnson Medical, Inc.
General Hospital · 154d
Cleared Apr 16, 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · KQJ
Crestat Diagnostics, Inc.
Hematology · 117d
Cleared Apr 16, 1997
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K970099 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 93d
Cleared Apr 16, 1997
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
K970173 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 90d
Cleared Apr 16, 1997
PIXI BONE DENSITOMETER
K970224 · KGI
Lunar Corp.
Radiology · 85d
Cleared Apr 16, 1997
EDTA CAVIT
K970246 · EBF
Karolinski
Dental · 85d
Cleared Apr 16, 1997
INNOVASIVE 8MM LIGAMENT FASTENER
K970316 · MBI
Innovasive Devices, Inc.
Orthopedic · 82d