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
88825–88848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1998
SULLIVAN AUTOSET
K980721 · BZD
Resmed, Ltd.
Anesthesiology · 189d
Cleared Sep 01, 1998
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
K980762 · DTM
Pall Corp.
Cardiovascular · 186d
Cleared Sep 01, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND...
K981168 · LPN
Allergan, Inc.
Ophthalmic · 153d
Cleared Sep 01, 1998
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER
K981952 · GEX
Instruments For Medicine and Diagnostics
General & Plastic Surgery · 90d
Cleared Sep 01, 1998
ESOPHAGEAL STETHOSCOPE
K982193 · BZT
Shore Medical, Inc.
Anesthesiology · 71d
Cleared Sep 01, 1998
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
K982345 · JAA
Cardiac Mariners, Inc.
Radiology · 57d
Cleared Sep 01, 1998
ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2...
K982501 · JIX
Alko Diagnostic Corp.
Chemistry · 43d
Cleared Sep 01, 1998
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC)...
K982904 · LPL
Les Laboratoires Blanchard
Ophthalmic · 14d
Cleared Aug 31, 1998
IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
K964977 · LFF
Interactive Living Systems, Inc.
Physical Medicine · 627d
Cleared Aug 31, 1998
HEMOSITE TEST SYSTEM
K973649 · KHG
Gds Technology, LLC
Microbiology · 340d
Cleared Aug 31, 1998
VAPAMASTA 6
K980489 · CAD
Medical Industrial Equipment
Anesthesiology · 203d
Cleared Aug 31, 1998
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
K981066 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 160d
Cleared Aug 31, 1998
THE BAGNOLI-4 EMG SYSTEM
K981934 · HCC
Delsys, Inc.
Neurology · 90d
Cleared Aug 31, 1998
MP-3 POWER BASE CHAIR
K982066 · ITI
Merits Health Products., Inc.
Physical Medicine · 81d
Cleared Aug 31, 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · JDW
Howmedica Corp.
Orthopedic · 80d
Cleared Aug 31, 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · DXE
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Aug 31, 1998
SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K982155 · MBI
Influence, Inc.
Orthopedic · 74d
Cleared Aug 31, 1998
SCOUT
K982158 · ITI
Burke, Inc.
Physical Medicine · 73d
Cleared Aug 31, 1998
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR...
K982248 · LPH
Howmedica, Inc.
Orthopedic · 66d
Cleared Aug 31, 1998
DEPUY ACE TIMAX PILON PLATE
K982347 · HRS
Depuy Ace Medical Co.
Orthopedic · 56d
Cleared Aug 31, 1998
MANUAL WHEELCHAIR
K982607 · IOR
G. Hirsch and Co., Inc.
Physical Medicine · 35d
Cleared Aug 31, 1998
UNI/MONOPOLAR HF CABLE
K982677 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 31d
Cleared Aug 31, 1998
PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
K982900 · MAI
Depuy, Inc.
Orthopedic · 14d
Cleared Aug 28, 1998
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
K981011 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 163d