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
92713–92736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1997
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 441d
Cleared Jul 17, 1997
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
K965123 · INI
Burke, Inc.
Physical Medicine · 244d
Cleared Jul 17, 1997
MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)
K970471 · LFL
Mentor Corp.
General & Plastic Surgery · 160d
Cleared Jul 17, 1997
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
K971189 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 107d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · GJT
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · GJT
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 17, 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · MOI
Chiron Diagnostics Corp.
Chemistry · 92d
Cleared Jul 17, 1997
SOMNOPLASTY SYSTEM
K971450 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jul 17, 1997
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · JEC
Howmedica Corp.
Orthopedic · 66d
Cleared Jul 17, 1997
CREATINE KINASE (CK)
K972155 · CGS
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K972297 · JFJ
Trace America, Inc.
Chemistry · 28d
Cleared Jul 16, 1997
NEEDLE-FREE VALVED CONNECTOR AND CAP
K964439 · FPA
Bmw Medical, Inc.
General Hospital · 252d
Cleared Jul 16, 1997
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
K964821 · DQA
Ventrex, Inc.
Anesthesiology · 226d
Cleared Jul 16, 1997
OXIMETER PRE-AMP CABLE
K965172 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 204d
Cleared Jul 16, 1997
SCT 3000 HEATED HUMIDIFIER
K970478 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 159d
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