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
94297–94320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1997
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
K955487 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 504d
Cleared Apr 18, 1997
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K961972 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 333d
Cleared Apr 18, 1997
QUARTET CLINICAL SYSTEM
K963761 · BZD
Respironics, Inc.
Anesthesiology · 212d
Cleared Apr 18, 1997
QFC UMBILICAL CLAMP
K963889 · HFW
Qfc Industries
Obstetrics & Gynecology · 204d
Cleared Apr 18, 1997
CAPNOCHECK PLUS
K970209 · CCK
Bci Intl., Inc.
Anesthesiology · 87d
Cleared Apr 18, 1997
POWERED TOOTHBRUSH
K970381 · JEQ
Emjoi Action USA, Ltd.
Dental · 74d
Cleared Apr 17, 1997
ALEXANDER BOX, BATTERY, RECHARGEABLE
K963305 · BWA
Alexander Mfg. Co.
Cardiovascular · 238d
Cleared Apr 17, 1997
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
K964585 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 153d
Cleared Apr 17, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
K965035 · JIQ
Beckman Instruments, Inc.
Immunology · 121d
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