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
86809–86832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1999
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
K984582 · MKJ
Bio-Detek, Inc.
Cardiovascular · 83d
Cleared Mar 16, 1999
CARESIDE AST
K990009 · CIT
Careside, Inc.
Chemistry · 71d
Cleared Mar 16, 1999
ALADDIN II MONITORING OXYGEN/AIR MONITOR
K990293 · BZR
Hamilton Medical, Inc.
Anesthesiology · 46d
Cleared Mar 15, 1999
LOKKI DT
K980840 · GEX
Hillard W. Welch
General & Plastic Surgery · 376d
Cleared Mar 15, 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955 · LTZ
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 284d
Cleared Mar 15, 1999
ENTERO-TEST HP, MODEL #102-01
K983119 · LIO
Hdc Corp.
Microbiology · 188d
Cleared Mar 15, 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · HHT
Harwill Medical (Pty) , Ltd.
Obstetrics & Gynecology · 182d
Cleared Mar 15, 1999
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
K983228 · NYN
Murray Electronics
Neurology · 181d
Cleared Mar 15, 1999
BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
K983295 · FLL
Braun AG
General Hospital · 175d
Cleared Mar 15, 1999
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K983385 · LCJ
Hutchison Intl., Inc.
General & Plastic Surgery · 171d
Cleared Mar 15, 1999
ITI DENTAL IMPLANT SYSTEM
K983742 · DZE
Institut Straumann AG
Dental · 143d
Cleared Mar 15, 1999
IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
K983835 · JWH
Implex Corp.
Orthopedic · 136d
Cleared Mar 15, 1999
MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO...
K983882 · HXR
Micro-Medical Devices, Inc.
General & Plastic Surgery · 133d
Cleared Mar 15, 1999
HEMOSLEEVE, MODEL 4.0MM, 5.5MM
K984018 · GEI
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 123d
Cleared Mar 15, 1999
BACK-ON-TRAC, MODEL 101BOT
K984190 · HST
Back-On-Track, Inc.
Neurology · 112d
Cleared Mar 15, 1999
EXCELSIOR PORCELAIN SYSTEM
K984427 · EIH
Ney Dental, Inc.
Dental · 94d
Cleared Mar 15, 1999
TIGRAN HIP PROSTHESIS
K984492 · LPH
Ponmed , Ltd.
Orthopedic · 88d
Cleared Mar 15, 1999
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · GXQ
W.L. Gore & Associates, Inc.
Neurology · 84d
Cleared Mar 15, 1999
THE BIOPLATE SHUNT CONNECTOR
K984583 · JXG
Biomedics
Neurology · 81d
Cleared Mar 15, 1999
DRG MEDIUM SCREW SYSTEM
K990019 · HWC
Dolphin Medical Technologies, Inc.
Orthopedic · 70d
Cleared Mar 15, 1999
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089 · GAP
Aesculap, Inc.
General & Plastic Surgery · 63d
Cleared Mar 15, 1999
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
K990152 · HSB
Howmedica Osteonics Corp.
Orthopedic · 55d
Cleared Mar 15, 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309 · KWL
Plus Orthopedics
Orthopedic · 42d
Cleared Mar 15, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
K990391 · JJY
Bio-Rad
Chemistry · 34d