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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140233–140256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1987
ACUSON TV519 TRANSDUCER
K864578 · HGL
Acuson Computed Sonography
Obstetrics & Gynecology · 127d
Cleared Mar 27, 1987
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
K864831 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 27, 1987
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K864908 · HGL
Diasonics, Inc.
Obstetrics & Gynecology · 102d
Cleared Mar 27, 1987
POWDERED BICARBONATE CONCENTRATE
K865078 · KPO
Bicarbolyte Corp.
Gastroenterology & Urology · 88d
Cleared Mar 27, 1987
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · GBX
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 35d
Cleared Mar 27, 1987
7.5 MHZ ENDOVAGINAL PROBE
K870709 · HGL
Philips Ultrasound, Inc.
Obstetrics & Gynecology · 35d
Cleared Mar 27, 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · DRQ
A&D Engineering, Inc.
Cardiovascular · 31d
Cleared Mar 27, 1987
ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)
K870835 · BZQ
Applied Membrane Technology, Inc.
Anesthesiology · 24d
Cleared Mar 27, 1987
PHARMASEAL WOUND CARE DRESSING PAD
K870941 · KOZ
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 18d
Cleared Mar 26, 1987
OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
K864466 · CAF
Omron Tateisi Electronics Co.
Anesthesiology · 134d
Cleared Mar 26, 1987
INTRAMEDULLARY NAIL
K870040 · HSB
The Deca Co.
Orthopedic · 80d
Cleared Mar 26, 1987
MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
K870255 · BZT
Transcor, Inc.
Anesthesiology · 63d
Cleared Mar 26, 1987
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
K870775 · HQE
Entravision, Inc.
Ophthalmic · 28d
Cleared Mar 26, 1987
NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
K870806 · HQC
United Surgical Corp.
Ophthalmic · 28d
Cleared Mar 26, 1987
BIO-VENT REUTER BOBBIN TUBE
K870877 · ETD
Richards Medical Co., Inc.
Ear, Nose, Throat · 23d
Cleared Mar 25, 1987
AGAR 7K TENS INSTRUMENT
K862454 · GZJ
Solcoor, Inc.
Neurology · 271d
Cleared Mar 25, 1987
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
K862632 · HSX
Zimmer, Inc.
Orthopedic · 258d
Cleared Mar 25, 1987
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K864662 · LJP
American Micro Scan
Microbiology · 117d
Cleared Mar 25, 1987
ALADIN (TM)
K865062 · LRG
Analytical Products, Inc.
Microbiology · 91d
Cleared Mar 25, 1987
KAMINSKY COMBINATION STENT & INJECTION CATHETER
K865085 · FAD
Van-Tec, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 25, 1987
VAN-TEC DOUBLE SHEATH GRASPING FORCEPS
K865087 · OCZ
Van-Tec, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 25, 1987
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
K870029 · GWC
American Micro Scan
Microbiology · 79d
Cleared Mar 25, 1987
VP2000 INFUSION PUMP
K870279 · FRN
Vickers , Ltd.
General Hospital · 57d
Cleared Mar 25, 1987
BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75
K870300 · KPR
Belmont Equipment Corp.
Radiology · 56d