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
81529–81552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2000
INVIDOS
K002051 · IYE
Scanditronix Medical AB
Radiology · 61d
Cleared Sep 05, 2000
LINEZOLID, 30UG, BBL SENSI-DISC
K002165 · JTN
Dickinson, and Co.
Microbiology · 49d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · DHR
Roche Diagnostics Corp.
Immunology · 14d
Cleared Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · MUJ
Nomos Corp.
Radiology · 309d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994103 · ITX
Olympus America, Inc.
Radiology · 274d
Cleared Sep 01, 2000
STRATO X
K002432 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Sep 01, 2000
FENNING HIP STEM
K002441 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 23d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · KKX
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 197d
Cleared Aug 31, 2000
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
K000700 · CCL
Sensidyne, Inc.
Anesthesiology · 183d
Cleared Aug 31, 2000
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K000919 · GWQ
Excel Tech. , Ltd.
Neurology · 162d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Aug 31, 2000
IMPULSE SELECT
K001579 · NFB
Airsep Corp.
Anesthesiology · 101d
Cleared Aug 31, 2000
ATHOS
K001704 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 87d
Cleared Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · JDQ
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Aug 31, 2000
3D ACTIVETRAC
K001712 · ITH
The Saunders Group
Physical Medicine · 87d
Cleared Aug 31, 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760 · LXT
Biomet, Inc.
Orthopedic · 83d
Cleared Aug 31, 2000
VASOTRAX
K001898 · DXN
Medwave, Inc.
Cardiovascular · 70d
Cleared Aug 31, 2000
OLEEVA FOAM
K002109 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 50d
Cleared Aug 31, 2000
LINEAGE ACETABULAR SYSTEM
K002149 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Aug 31, 2000
RD-2104
K002222 · EJT
J.F. Jelenko & Co., Inc.
Dental · 38d
Cleared Aug 31, 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · DRF
Biosense Webster, Inc.
Cardiovascular · 30d