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
73249–73272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 252d
Cleared Nov 19, 2002
ORIA SPINAL CLIP SYSTEM
K021679 · KWP
Ortho Tec, LLC
Orthopedic · 182d
Cleared Nov 19, 2002
ASSUFIL
K021767 · GAM
Assut Europe S.P.A.
General & Plastic Surgery · 174d
Cleared Nov 19, 2002
INSOUND XT SERIES HEARING AID
K021867 · ESD
Insound Medical, Inc.
Ear, Nose, Throat · 166d
Cleared Nov 19, 2002
HIP MODULE FOR THE STEALTHSTATION SYSTEM
K021980 · HAW
Medtronic Surgical Navigation...
Neurology · 155d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · NBC
Roche Diagnostics Corp.
Chemistry · 112d
Cleared Nov 19, 2002
PHFW-10
K022539 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 110d
Cleared Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · LYL
Ciba Vision Corporation
Ophthalmic · 98d
Cleared Nov 19, 2002
MANUAL TOUCHE SYSTEM
K022777 · GAQ
Onux Medical, Inc.
General & Plastic Surgery · 90d
Cleared Nov 19, 2002
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
K022783 · DXN
Tensys Medical, Inc.
Cardiovascular · 89d
Cleared Nov 19, 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES...
K022798 · KWQ
Corin USA
Orthopedic · 88d
Cleared Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · GZJ
Biomedical Life Systems, Inc.
Neurology · 84d
Cleared Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · GZJ
Biomedical Life Systems, Inc.
Neurology · 76d
Cleared Nov 19, 2002
THE BIOPLATE BATTERY POWERED DRILL
K022986 · HBC
Bioplate, Inc.
Neurology · 71d
Cleared Nov 19, 2002
MONARC SLING SYSTEM
K023516 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 19, 2002
EASY LIFE
K023521 · INO
Berkline Corp.
Physical Medicine · 29d
Cleared Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · MQP
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Nov 19, 2002
STORM TDX POWER WHEELCHAIR
K023589 · ITI
Invacare Corp.
Physical Medicine · 25d
Cleared Nov 19, 2002
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
K023601 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 22d
Cleared Nov 19, 2002
TILITE YG AND TILITE YGS
K023606 · IOR
Tisport
Physical Medicine · 22d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Nov 19, 2002
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
K023698 · MHX
Philips Medical Systems
Cardiovascular · 15d
Cleared Nov 19, 2002
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749 · DRG
Philips Medical Systems
Cardiovascular · 11d
Cleared Nov 18, 2002
RENAX HEMODIALYSIS BLOOD TUBING SET
K014140 · FJK
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 336d