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
72001–72024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 2003
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K012889 · MED
Pascal Co., Inc.
General Hospital · 637d
Cleared May 27, 2003
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
K023937 · DYB
Cook Vascular, Inc.
Cardiovascular · 182d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 27, 2003
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · BSP
Wilson-Cook Medical, Inc.
Anesthesiology · 90d
Cleared May 27, 2003
APTUS BLUE
K030884 · KJJ
Acadental
Dental · 68d
Cleared May 27, 2003
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · MCW
Rex Medical
Cardiovascular · 5d
Cleared May 23, 2003
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
K030039 · KPI
The Prometheus Group
Gastroenterology & Urology · 137d
Cleared May 23, 2003
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
K030230 · DXN
Avita Corporation
Cardiovascular · 121d
Cleared May 23, 2003
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K030398 · DQR
Cardiacassist, Inc.
Cardiovascular · 106d
Cleared May 23, 2003
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
K030592 · KDI
Gambro Renal Care Products
Gastroenterology & Urology · 87d
Cleared May 23, 2003
DEFLECTING URETERAL ACCESS SHEATH
K030642 · FED
Applied Medical Resources Corp.
Gastroenterology & Urology · 84d
Cleared May 23, 2003
AMSURE FOLEY INSERTION TRAY
K030664 · FCM
Amsino International, Inc.
Gastroenterology & Urology · 81d
Cleared May 23, 2003
AMSURE URETHRAL CATHETERIZATION TRAY
K030712 · FCM
Amsino International, Inc.
Gastroenterology & Urology · 78d
Cleared May 23, 2003
FYRELINK VL
K030728 · LLZ
Mpacs, LLC
Radiology · 77d
Cleared May 23, 2003
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
K030827 · HAW
Orthosoft, Inc.
Neurology · 70d
Cleared May 23, 2003
ULTRAEKOGEL MODELS EK 2000 & EK 2001
K030889 · MUI
Inmed Ltda.
Radiology · 63d
Cleared May 23, 2003
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
K030930 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 59d
Cleared May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · FED
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared May 23, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K031076 · LYZ
Synmertex Co, Ltd.
General Hospital · 49d
Cleared May 23, 2003
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
K031117 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 45d
Cleared May 23, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K031120 · LYZ
Synmertex Co, Ltd.
General Hospital · 45d
Cleared May 23, 2003
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
K031171 · LYZ
Synmertex Co, Ltd.
General Hospital · 39d
Cleared May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
K031209 · MOS
Ge Medical Systems, Inc.
Radiology · 36d
Cleared May 23, 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K031217 · LZO
Howmedica Osteonics
Orthopedic · 36d