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
93241–93264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1997
ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
K971414 · LZO
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 91d
Cleared Jul 16, 1997
OLYMPUS OES OTV-S5C VIDEO SYSTEM
K971416 · FET
Olympus America, Inc.
Gastroenterology & Urology · 91d
Cleared Jul 16, 1997
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
K971457 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 110d
Cleared Jul 16, 1997
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT...
K971461 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 86d
Cleared Jul 16, 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497 · LZO
Osteonics Corp.
Orthopedic · 83d
Cleared Jul 16, 1997
P.F.C. SIGMA INSET PATELLA
K971652 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 71d
Cleared Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741 · JDQ
Howmedica Corp.
Orthopedic · 65d
Cleared Jul 16, 1997
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT...
K972027 · ELW
Zhermack S.P.A.
Dental · 44d
Cleared Jul 15, 1997
VISUALEYES: VIDEO EYE MONITOR
K964325 · GWN
Micromedical Technologies, Inc.
Neurology · 258d
Cleared Jul 15, 1997
VIDEO EYE TRAKKER
K964646 · GWN
Micromedical Technologies, Inc.
Neurology · 237d
Cleared Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068 · LNH
Toshiba America Medical Systems, In.C
Radiology · 209d
Cleared Jul 15, 1997
UNIJECT SURGICAL GLOVES
K970160 · KGO
Uniject Gloves , Ltd.
General Hospital · 180d
Cleared Jul 15, 1997
CONFOCAL MICROSCOPE
K970414 · HJO
Con-S , Ltd.
Ophthalmic · 173d
Cleared Jul 15, 1997
ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
K970683 · EBF
Foremost Dental Mfg., Inc.
Dental · 141d
Cleared Jul 15, 1997
SMILE WITH CONFIDENCE
K971002 · EHS
Lloyd V. Ziemendorf
Dental · 118d
Cleared Jul 15, 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · MEB
Baxter Healthcare Corp
General Hospital · 106d
Cleared Jul 15, 1997
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
K971355 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 95d
Cleared Jul 15, 1997
LL BI-FOCAL, DAILY WEAR CONTACT LENS
K971647 · LPL
Lombart Lenses, Ltd.
Ophthalmic · 71d
Cleared Jul 15, 1997
BIVALVE NASAL SPLINT
K972096 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 837d
Cleared Jul 14, 1997
COBE CENTURY PERFUSION PUMP
K960974 · DWB
Cobe Cardiovascular, Inc.
Cardiovascular · 490d
Cleared Jul 14, 1997
GANTEX MODEL NSG-75PF
K962539 · KGO
American Pro Latex, Inc.
General Hospital · 381d
Cleared Jul 14, 1997
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · JXE
Neurotron Medical
Neurology · 332d
Cleared Jul 14, 1997
MRI NEEDLES
K963565 · FCG
Cook, Inc.
Gastroenterology & Urology · 312d