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
93145–93168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1997
B SMART MODEL 1
K961817 · LEL
Koven Technology, Inc.
Neurology · 439d
Cleared Jul 23, 1997
STREP A OIA MAX
K962060 · GTZ
Biostar, Inc.
Microbiology · 421d
Cleared Jul 23, 1997
CAMOUFLAGE CUFF SAVERS
K963987 · DXQ
N.A. Braggs Medical, Inc.
Cardiovascular · 292d
Cleared Jul 23, 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · DPS
Instromedix, Inc.
Cardiovascular · 261d
Cleared Jul 23, 1997
TARGET 2 VERSION 1.1
K965010 · IYE
GE Medical Systems
Radiology · 219d
Cleared Jul 23, 1997
ULTIMA TPS CEMENTED STEM
K965198 · KWL
Johnson & Johnson International
Orthopedic · 209d
Cleared Jul 23, 1997
ENVOY GUIDING CATHETER
K965247 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 211d
Cleared Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
K971165 · LDF
Boston Scientific Corp
Cardiovascular · 114d
Cleared Jul 23, 1997
BETTER HEARING, INC. MODEL L-1 HEARING AID
K971298 · ESD
Better Hearing, Inc.
Ear, Nose, Throat · 107d
Cleared Jul 23, 1997
FREERIDER, MODEL FR510-F
K971387 · INI
Freerider USA, Inc.
Physical Medicine · 100d
Cleared Jul 23, 1997
FREERIDER, MODEL FR168-4
K971388 · INI
Freerider USA, Inc.
Physical Medicine · 100d
Cleared Jul 23, 1997
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER
K971516 · LIT
Cordis Corp.
Cardiovascular · 86d
Cleared Jul 23, 1997
ARTHROCARE ELECTROSURGERY SYSTEM
K971532 · GEI
Arthrocare Corp.
General & Plastic Surgery · 86d
Cleared Jul 23, 1997
SHARPLAN ERBIUM: YAG LASER (4020)
K971648 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 79d
Cleared Jul 23, 1997
CARDIAC PHASED ARRAY COIL
K971667 · MOS
GE Medical Systems
Radiology · 78d
Cleared Jul 23, 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 78d
Cleared Jul 23, 1997
MICRO-SEAL ACETABULAR SYSTEM
K971718 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 75d
Cleared Jul 23, 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · MID
Zeus Scientific, Inc.
Immunology · 70d
Cleared Jul 23, 1997
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
K971843 · GEX
Laserscope
General & Plastic Surgery · 70d
Cleared Jul 23, 1997
SLED, FINGER, HANDLE
K971942 · ITX
Biosound Esaote, Inc.
Radiology · 57d
Cleared Jul 23, 1997
MYRINGOTOMY TUBE
K971943 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 23, 1997
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
K971968 · DSA
Remington Medical, Inc.
Cardiovascular · 56d
Cleared Jul 23, 1997
TARGET CARDIAC TROPONIN I TEST
K972094 · MMI
Texas Immunology, Inc.
Chemistry · 49d
Cleared Jul 23, 1997
FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · CAK
Baxter Healthcare Corp
General Hospital · 44d