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
109993–110016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 1994
NDM HYDROGAUZE WOUND DRESSING
K934601 · NAE
Ndm Acquisition Corp.
General & Plastic Surgery · 144d
Cleared Feb 15, 1994
SURGICAL VIDEO CAMERA AND ACCESSORIES
K934682 · FWF
Medical Dynamics, Inc.
General & Plastic Surgery · 138d
Cleared Feb 15, 1994
BABY BOARD
K935098 · BTX
Sentry Medical Products, Inc.
General & Plastic Surgery · 113d
Cleared Feb 15, 1994
FLUID ASPIRATION NEEDLE
K935293 · GCJ
Surgin Surgical Instrumentation, Inc.
General & Plastic Surgery · 104d
Cleared Feb 15, 1994
GRASPERS
K935382 · GCJ
Mectra Labs, Inc.
General & Plastic Surgery · 99d
Cleared Feb 15, 1994
EXTRACORPOREAL TEMPERATURE SENSOR
K935603 · FLL
Smiths Industries Medical Systems, Inc.
General Hospital · 89d
Cleared Feb 15, 1994
ALLEVYN ISLAND WOUND DRESSING
K935705 · NAE
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Feb 15, 1994
O.R. BASIN SET TRAY
K935741 · LRO
Cush Medical Products
General Hospital · 76d
Cleared Feb 15, 1994
BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING
K935848 · NAE
Brady Medical Products Co.
General & Plastic Surgery · 69d
Cleared Feb 15, 1994
SURGICAL RETRACTOR KIT
K940193 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 33d
Cleared Feb 14, 1994
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · MEH
Depuy, Inc.
Orthopedic · 789d
Cleared Feb 14, 1994
EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
K920410 · FFK
Psi Medical Products, Inc.
Gastroenterology & Urology · 745d
Cleared Feb 14, 1994
ENDOSSEOUS IMPLANTS
K924219 · DZE
The Stern Metals Co., Inc.
Dental · 542d
Cleared Feb 14, 1994
ONCO-VIAL ADAPTER
K926071 · LHI
David Bull Laboratories, USA, Inc.
General Hospital · 440d
Cleared Feb 14, 1994
MINIBALL ABUTMENT
K930155 · DZE
Steri-Oss, Inc.
Dental · 397d
Cleared Feb 14, 1994
4-SURE FEMALE CATHETER
K931047 · EZD
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 350d
Cleared Feb 14, 1994
4-SURE NELATON CATHETER
K931048 · EZD
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 350d
Cleared Feb 14, 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · LYU
W.L. Gore & Associates, Inc.
General Hospital · 348d
Cleared Feb 14, 1994
GERITREX STERILE WATER FOR IRRIGATION
K931511 · JOL
Geritrex Corp.
General Hospital · 325d
Cleared Feb 14, 1994
PRO'S NEO-LASTICS
K932298 · ECI
Professional Positioners, Inc.
Dental · 279d
Cleared Feb 14, 1994
FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH
K932843 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 248d
Cleared Feb 14, 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · FMI
Sherwood Medical Co.
General Hospital · 195d
Cleared Feb 14, 1994
ACUFEX ARTHROSCOPE
K934270 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 167d
Cleared Feb 14, 1994
DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
K934299 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 165d