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
85345–85368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1999
GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
K992149 · GEI
Geiger Medical Technologies, Inc.
General & Plastic Surgery · 56d
Cleared Aug 19, 1999
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · GWF
Excel Tech. , Ltd.
Neurology · 41d
Cleared Aug 19, 1999
FUNNEL TROCAR
K992324 · GCJ
Patton Medical Corp.
General & Plastic Surgery · 38d
Cleared Aug 19, 1999
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
K992413 · DRT
Medical Data Electronics
Cardiovascular · 30d
Cleared Aug 19, 1999
B2C HIP SYSTEM
K992490 · JDI
Lepine Groupe Spa.
Orthopedic · 24d
Cleared Aug 19, 1999
MINI 6800 DIGITAL MOBILE C-ARM
K992506 · OXO
Ge Dec Medical Systems
Radiology · 23d
Cleared Aug 19, 1999
TSX PROBE, OCULAR CONTACT PROBE
K992508 · GEX
Instruments For Medicine and Diagnostics
General & Plastic Surgery · 23d
Cleared Aug 19, 1999
LAPAROCAM
K992541 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 20d
Cleared Aug 18, 1999
SUZANNE
K990565 · MNR
Nellcor Puritan Bennett, Inc.
Anesthesiology · 177d
Cleared Aug 18, 1999
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
K991273 · MQE
Swemed Lab International AB
Obstetrics & Gynecology · 127d
Cleared Aug 18, 1999
DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
K991283 · DZE
Micro Motors, Inc.
Dental · 125d
Cleared Aug 18, 1999
BIPOLAR SHOULDER PROSTHESIS
K991585 · KWT
Biomet, Inc.
Orthopedic · 103d
Cleared Aug 18, 1999
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
K991719 · CAZ
Medimex Holfeld GmbH & Co.
Anesthesiology · 90d
Cleared Aug 18, 1999
CUTANEOUS (BAR) ELECTRODE
K991769 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (GROUND) ELECTRODE
K991770 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
DIGITAL RING ELECTRDE
K991771 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (DISC) ELECTRODE
K991772 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
K-L-W INTRAORAL DISTRACTOR
K991875 · MQN
KLS-Martin L.P.
Dental · 77d
Cleared Aug 18, 1999
KSEA CALCUSPLIT
K992114 · FFK
Karl Storz Endoscopy
Gastroenterology & Urology · 57d
Cleared Aug 18, 1999
PRODIGY 4 TRANSLUCENT SHADES
K992118 · EBF
Sybron Dental Specialties, Inc.
Dental · 56d
Cleared Aug 18, 1999
NEXUS 2
K992160 · EMA
Sybron Dental Specialties, Inc.
Dental · 54d
Cleared Aug 18, 1999
DUTECK DIGITAL CLINICAL THERMOMETER
K992327 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 37d
Cleared Aug 18, 1999
UROSURGE SPIRALFLO URETERAL STENT
K992391 · FAD
Urosurge, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 18, 1999
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
K992411 · DRT
Medical Data Electronics
Cardiovascular · 29d