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
143065–143088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1986
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
K862611 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 15d
Cleared Jul 23, 1986
CONCEPT CURETTE
K862657 · HRX
Concept, Inc.
Orthopedic · 9d
Cleared Jul 23, 1986
CONCEPT ARTHROSCOPIC KNIFE
K862658 · HRX
Concept, Inc.
Orthopedic · 9d
Cleared Jul 22, 1986
ET/RT PAPILLOTOME
K860593 · KNS
Hobbs Medical, Inc.
Gastroenterology & Urology · 153d
Cleared Jul 22, 1986
CRITIKON 48-HOUR AIR ELIMINATING FILTER
K861644 · FPB
Critikon Company, LLC
General Hospital · 83d
Cleared Jul 22, 1986
PLAYTEX TAMPONS
K861738 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 77d
Cleared Jul 22, 1986
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
K861797 · CEW
Nichols Institute Diagnostics
Chemistry · 74d
Cleared Jul 22, 1986
O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER
K862015 · FIB
Bipore, Inc.
Gastroenterology & Urology · 55d
Cleared Jul 22, 1986
TRIGLYCERIDES
K862033 · CDT
Pointe Scientific, Inc.,
Chemistry · 55d
Cleared Jul 22, 1986
GINGERBREAD MAN (TM)
K862093 · BXB
Southern Pride Manufacturing, Inc.
Physical Medicine · 50d
Cleared Jul 22, 1986
SET CANAL SEALER PASTE
K862129 · EKM
Endo Technic Corp.
Dental · 48d
Cleared Jul 22, 1986
ALPHA ALL-IN-THE-EAR HEARING AID
K862169 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jul 22, 1986
PHONIC EAR PE 602 PPCS
K862229 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 22, 1986
DEN-MAT DENTIN LINK
K862449 · EBF
Den-Mat Corp.
Dental · 25d
Cleared Jul 22, 1986
MX MOBILE X-RAY SYSTEM
K862452 · IZL
Philips Medical Systems (Cleveland),...
Radiology · 25d
Cleared Jul 22, 1986
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · EBD
3M Company
Dental · 15d
Cleared Jul 22, 1986
TORAY FILTRYZER DIALYZER, B1-2.0.
K862693 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 11d
Cleared Jul 21, 1986
MANIQUICK PEDICURE & MANICURE SET
K861360
Quicklime Maniquick
General & Plastic Surgery · 102d
Cleared Jul 21, 1986
ENZYGNOST ANTI-CMV IGM TEST
K861363 · LKQ
Behring Diagnostics, Inc.
Microbiology · 102d
Cleared Jul 21, 1986
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
K861790 · DWF
Research Medical, Inc.
Cardiovascular · 73d
Cleared Jul 21, 1986
KOAGULAB* M COAGULATION SYSTEM
K862537 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 19d
Cleared Jul 21, 1986
LITE TOUCH GELFOAM INSERT
K862583
Treace Medical, Inc.
General & Plastic Surgery · 14d
Cleared Jul 18, 1986
PULSAR NEUROSTIMULATOR
K852061 · GZJ
Andromeda Research, Inc.
Neurology · 435d
Cleared Jul 18, 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 164d