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
71305–71328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 17, 2003
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · FGE
Rusch Intl.
Gastroenterology & Urology · 229d
Cleared Jun 17, 2003
TENS PRO 900
K023726 · GZJ
Acumed Medical Supplies , Ltd.
Neurology · 223d
Cleared Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Jun 17, 2003
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
K030528 · JIY
Clinical Data
Chemistry · 118d
Cleared Jun 17, 2003
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK...
K030531 · LZG
Minimed, Inc.
General Hospital · 118d
Cleared Jun 17, 2003
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
K030891 · HNO
Surgistar, Inc.
Ophthalmic · 88d
Cleared Jun 17, 2003
VMATE MODEL VMM1000
K030948 · HQE
Howard Instruments, Inc.
Ophthalmic · 83d
Cleared Jun 17, 2003
ONE-STEP PREGNANCY TEST
K031271 · LCX
Amerisource Pharmacal, Inc.
Chemistry · 56d
Cleared Jun 17, 2003
IMAGINE REFLEX
K031326 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d