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
71809–71832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2003
UFI GEL HARD C
K030916 · EBI
Voco GmbH
Dental · 87d
Cleared Jun 19, 2003
HEMCON BANDAGE OTC
K030946 · QSY
Hemcon, Inc.
General & Plastic Surgery · 85d
Cleared Jun 19, 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K031029 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 79d
Cleared Jun 19, 2003
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
K031041 · JCT
Bard Peripheral Vascular
General & Plastic Surgery · 79d
Cleared Jun 19, 2003
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · DTD
Oscor, Inc.
Cardiovascular · 66d
Cleared Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · MSV
Axis-Shield Diagnostics, Ltd.
Immunology · 66d
Cleared Jun 19, 2003
SOLUTION FACE MASKS
K031353 · FXX
A Plus International, Inc.
General Hospital · 51d
Cleared Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · IZQ
E-Z-Em, Inc.
Radiology · 30d
Cleared Jun 19, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K031626 · LJS
AngioDynamics, Inc.
General Hospital · 23d
Cleared Jun 18, 2003
DEMETECH NYLON NONABSORBABLE SUTURE
K023028 · GAR
Demetech Corp.
General & Plastic Surgery · 280d
Cleared Jun 18, 2003
DEMETECH POLYESTER NONABSORBABLE SUTURE
K023030 · GAT
Demetech Corp.
General & Plastic Surgery · 280d
Cleared Jun 18, 2003
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
K023335 · NJW
Qc Sciences, LLC
Pathology · 254d
Cleared Jun 18, 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · DQO
Deroyal Industries, Inc.
Cardiovascular · 236d
Cleared Jun 18, 2003
GYNE IDEAS MINITAPE RP DEVICE
K023898 · PAH
Gyne Ideas , Ltd.
Gastroenterology & Urology · 208d
Cleared Jun 18, 2003
CURAD SCAR THERAPY
K024057 · MDA
Beiersdorf, Inc.
General & Plastic Surgery · 191d
Cleared Jun 18, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K030654 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 107d
Cleared Jun 18, 2003
OMNILUX BLUE
K030883 · GEX
Photo Therapeutics Limited
General & Plastic Surgery · 90d
Cleared Jun 18, 2003
LUMEND FRONTRUNNER GW CTO CATHETER
K031005 · PDU
Lumend, Inc.
Cardiovascular · 79d
Cleared Jun 18, 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS...
K031231 · JJW
Bio-Rad
Chemistry · 61d
Cleared Jun 18, 2003
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
K031233 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 62d
Cleared Jun 18, 2003
LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
K031443 · NEW
Lsi Solutions
General & Plastic Surgery · 43d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · KWP
Ortho Tec, LLC
Orthopedic · 42d
Cleared Jun 18, 2003
NIM-SPINE
K031510 · ETN
Medtronic Xomed
Ear, Nose, Throat · 35d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Smith & Nephew, Inc.
Orthopedic · 27d