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
128905–128928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1989
URETHRAL AND URETERAL BALLOON DILATATORS
K884711 · EZN
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
COLONIC BALLOON DIALATORS
K884713 · FFP
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
BILIARY DIALATOR
K884714 · FGE
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
ACHELASIA BALLOON DIALATOR
K884715 · KNQ
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 29, 1989
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
K885229 · HSZ
Romano Surgical Instrumentation, Inc.
Orthopedic · 294d
Cleared Sep 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891341 · LYY
A.P. Rubber Co., Ltd.
General Hospital · 203d
Cleared Sep 29, 1989
SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
K891481 · LKD
Siemens Medical Electronics
Anesthesiology · 196d
Cleared Sep 29, 1989
FIBER OPTIC LIGHT TRANSMISSION CABLE
K892145 · FFS
Opto Vision, Inc.
Gastroenterology & Urology · 183d
Cleared Sep 29, 1989
PATIENT EXAM GLOVES(MFG: JIN DING ZAI JIE LATEX GL
K893696 · LYY
Double Scores , Ltd.
General Hospital · 136d
Cleared Sep 29, 1989
LATEX GLOVE, EXAMINATION
K893726 · LYY
Lixin Hygienical Products Factory...
General Hospital · 135d
Cleared Sep 29, 1989
CADWELL FREEDOM EEG DEVICE
K894276 · GWQ
Cadwell Laboratories, Inc.
Neurology · 98d
Cleared Sep 29, 1989
UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM
K894337 · CBI
Vitaid, Ltd.
Anesthesiology · 77d
Cleared Sep 29, 1989
CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
K894409 · IWA
Amersham Corp.
Radiology · 74d
Cleared Sep 29, 1989
DENVER PERITONEO-VENUS SHUNT
K894756 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 29, 1989
BIO-INDUSTRY STIM POCHE(R)
K894786 · BXN
The Hader Corp.
Anesthesiology · 59d
Cleared Sep 29, 1989
TRU-TRAX
K894851 · GIO
Humagen, Inc.
Hematology · 60d
Cleared Sep 29, 1989
PRENATAL WEDGE
K895343 · JFB
Kay Ent.
Physical Medicine · 28d
Cleared Sep 29, 1989
EXCEL LATEX PATIENT EXAMINATION GLOVES
K895494 · LYY
Alpha Glove Sdn. Bhd.
General Hospital · 32d
Cleared Sep 28, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)
K891588 · LQR
Ideal Medical, Inc.
Gastroenterology & Urology · 195d
Cleared Sep 28, 1989
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · DJG
Diagnostic Products Corp.
Chemistry · 192d
Cleared Sep 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892586 · LYY
Modlook Industries , Ltd.
General Hospital · 170d
Cleared Sep 28, 1989
ACL DRILL GUIDE SYSTEM
K892655 · LXI
Baxter Healthcare Corp
Orthopedic · 168d
Cleared Sep 28, 1989
MITEK DRILL GUIDE
K892904 · HXY
Mitek Surgical Products, Inc.
Orthopedic · 161d
Cleared Sep 28, 1989
KIT- CIBA CORNING L-TDM I, II, III
K893682 · DIF
Ciba Corning Diagnostics Corp.
Chemistry · 135d