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
71497–71520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 23, 2003
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
K031262 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 32d
Cleared May 23, 2003
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
K031344 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 24d
Cleared May 23, 2003
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
K031361 · FPA
Deltec, Inc.
General Hospital · 23d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared May 23, 2003
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · BZH
Monaghan Medical Corp.
Anesthesiology · 9d
Cleared May 22, 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · MNW
Avita Corporation
Gastroenterology & Urology · 442d
Cleared May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · HSX
Tornier
Orthopedic · 318d
Cleared May 22, 2003
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 211d
Cleared May 22, 2003
EASYCUP
K023823 · JHI
Zer Hitech
Chemistry · 188d