FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
105529–105552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1995
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K945186 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- CALCAR PLANER
K945189 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K945208 · HWE
U.S. Medical Products, Inc.
Orthopedic · 94d
Cleared Jan 27, 1995
SELF-LATCHING CLIP
K945231 · FZP
Surgical System, Inc.
General & Plastic Surgery · 92d
Cleared Jan 27, 1995
AS/3 MEMORY MODULE, M0MEM
K945234 · BSZ
Datex Division Instrumentarium Corp.
Anesthesiology · 92d
Cleared Jan 27, 1995
INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
K945394 · GCJ
Innovative Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Jan 27, 1995
HEMOCLIP ECOSYSTEM
K945520 · GCJ
Pilling Weck, Inc.
General & Plastic Surgery · 78d
Cleared Jan 27, 1995
GLENROE ORTHO-SIL
K945535 · EGD
Glenroe Technologies
Dental · 74d
Cleared Jan 27, 1995
3M(TM) EAR IMPRESSION MATERIAL
K945726 · ESD
3M Medical Products Group
Ear, Nose, Throat · 66d
Cleared Jan 27, 1995
ADVANCE(R) PREGNANCY TEST
K945846 · LCX
Advanced Care Products
Chemistry · 58d
Cleared Jan 27, 1995
MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM
K945888 · GEX
Luxar Corp.
General & Plastic Surgery · 57d
Cleared Jan 27, 1995
MASK, GAS, ANESTHETIC
K945894 · BSJ
Hans Rudolph, Inc.
Anesthesiology · 56d
Cleared Jan 27, 1995
RAPIDVUE(TM) HCG
K945969 · JHI
Quidel Corp.
Chemistry · 51d
Cleared Jan 27, 1995
KSEA STEINER ELECTROMECHANIC MORCELLATORT
K946213 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 37d
Cleared Jan 27, 1995
ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR
K946241 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 36d
Cleared Jan 27, 1995
THERMASET
K946255 · DYH
Ormco Corp.
Dental · 36d
Cleared Jan 27, 1995
WGL ENDOSCOPIC GRASPER*
K950063 · GCJ
Wilson Greatbatch Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Jan 27, 1995
FISONEB(R) II
K950206 · CAF
Fisons Corp.
Anesthesiology · 9d
Cleared Jan 26, 1995
BERNSTEIN(TM) UTERINE MANIPULATOR
K932394 · LKF
Gm Engineering, Inc.
Obstetrics & Gynecology · 618d
Cleared Jan 26, 1995
TOHP-CAP
K941031 · FMI
Jrm Ent., Inc.
General Hospital · 328d
Cleared Jan 26, 1995
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
K941622 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 297d
Cleared Jan 26, 1995
MRT-150A, MRT-150A SOFTWARE VERSION 11.9
K941864 · LNH
Toshiba America Mri, Inc.
Radiology · 283d
Cleared Jan 26, 1995
ORAL STEEL CARTRIDGE SYRINGE
K941915 · EJI
Robert W. Bauer & Assoc., Inc.
Dental · 282d
Cleared Jan 26, 1995
LINK SADDLE PROTHESIS
K943277
Turnkey Intergration USA, Inc.
General & Plastic Surgery · 203d