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
130945–130968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
ARGELOY N.P.
K893686 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Jun 23, 1989
TECNOL GAITERS PRODUCT NUMBER 47725-010
K893702 · FXP
Tecnol New Jersey Wound Care, Inc.
General Hospital · 36d
Cleared Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
LIFECELL RECOVERY CONTAINER
K893787 · KJF
Baxter Healthcare Corp
Pathology · 32d
Cleared Jun 23, 1989
BREATHING MOUTHPIECE
K893791 · BYP
Diemolding Corp.
Anesthesiology · 32d
Cleared Jun 23, 1989
ACCESS TM
K893881 · LNH
Diasonics, Inc.
Radiology · 28d
Cleared Jun 23, 1989
SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
K893897 · LKJ
Biostar Medical Products, Inc.
Immunology · 24d
Cleared Jun 22, 1989
SEER
K882818 · DSI
Marquette Electronics, Inc.
Cardiovascular · 349d
Cleared Jun 22, 1989
ACTA GENOS ELECTROCARDIOGRAPH
K884800 · DPS
Parexel Intl. Corp.
Cardiovascular · 218d
Cleared Jun 22, 1989
SELBY INSTRUMENTATION
K884998 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 202d
Cleared Jun 22, 1989
SURGICAL GLOVES
K885089 · KGO
Wb Intl., Inc.
General Hospital · 192d
Cleared Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102 · LZO
Osteonics Corp.
Orthopedic · 192d
Cleared Jun 22, 1989
APR COLLARED REVISION FEMORAL COMPONENT
K885192 · JDI
Intermedics Orthopedics
Orthopedic · 188d
Cleared Jun 22, 1989
SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.
K885349 · DXK
Sonotek Corp.
Cardiovascular · 176d
Cleared Jun 22, 1989
PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
K890292 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 154d
Cleared Jun 22, 1989
BP-8800 BLOOD PRESSURE MONITOR
K890876 · DRT
Colin Medical Instruments Corp.
Cardiovascular · 121d
Cleared Jun 22, 1989
TERUMO AV FISTULA NEEDLE SET
K891062 · FIE
Terumo Medical Corp.
Gastroenterology & Urology · 113d
Cleared Jun 22, 1989
HUGH YOUNG II UROLOGICAL TABLE
K891403 · IZZ
Mallinckrodt Group, Inc.
Radiology · 100d
Cleared Jun 22, 1989
LATEX EXAMINATION GLOVES, STYLE 510 LX
K891418 · LYY
C & K Mfg. & Sales Co.
General Hospital · 100d
Cleared Jun 22, 1989
BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)
K891835 · LYZ
Associated Ent., Inc.
General Hospital · 87d
Cleared Jun 22, 1989
WINFIELD LATEX EXAMINATION GLOVES
K891855 · LYY
Winfield Co., Inc.
General Hospital · 87d
Cleared Jun 22, 1989
TRU-TOUCH VINYL EXAM GLOVES (CANADA)
K891952 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Jun 22, 1989
PURAFLEX PATIENT EXAMINATION GLOVES
K892017 · LYY
Medsi, Inc.
General Hospital · 84d