FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92641–92664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 23, 1997
DEEG-LITE
K972202 · GWQ
Grass-Telefactor Product Group
Neurology · 42d
Cleared Jul 23, 1997
AMMONIA/IRON STANDARD KIT
K972333 · JIX
Verichem Laboratories, Inc.
Chemistry · 30d
Cleared Jul 23, 1997
MIRACLE-EAR DIGITAL BTE
K972344 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
DAHLBERG/MIRACLE-EAR
K972345 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
MIRACLE-EAR ITE DIGITAL
K972346 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
MYRINGOTOMY TUBE - BOBBIN WITH TAB
K972400 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 23, 1997
MERIDIAN DSP
K972431 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
JAZZ PP AGC-O, JAZZ PP
K972542 · ESD
Trutone
Ear, Nose, Throat · 14d
Cleared Jul 23, 1997
TWIST PPAGC-1, TWIST PP
K972543 · ESD
Trutone
Ear, Nose, Throat · 14d