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
108169–108192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1994
SUPER/FLUFF SPONGES
K942106 · EFQ
Lorrex Health Products
General & Plastic Surgery · 17d
Cleared May 18, 1994
DUO DENT
K923694 · DZE
Pdc Management Services, Inc.
Dental · 664d
Cleared May 18, 1994
POLLENEX HEPA AIR CLEANERS
K925055 · FRF
Pollenex Corp.
General Hospital · 589d
Cleared May 18, 1994
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG
K931676 · JDL
Joint Medical Products Corp.
Orthopedic · 407d
Cleared May 18, 1994
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
K932404 · FMC
Safeskin Corp.
General Hospital · 370d
Cleared May 18, 1994
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
K932405 · FMC
Safeskin Corp.
General Hospital · 370d
Cleared May 18, 1994
CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM
K933499 · LZO
U.S. Medical Products, Inc.
Orthopedic · 303d
Cleared May 18, 1994
FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
K933652 · FRN
Repro-Med Systems, Inc.
General Hospital · 294d
Cleared May 18, 1994
URINARY DRAINAGE BAG
K934080 · EYT
Kit Pak, Inc.
Gastroenterology & Urology · 271d
Cleared May 18, 1994
BON APATITE HA PARTICLES
K934430 · LYC
Bio-Interfaces, Inc.
Dental · 247d
Cleared May 18, 1994
AUTO SUTURE DISPOSABLE LIGHT CABLE
K934531 · FCW
United States Surgical, A Division of...
Gastroenterology & Urology · 240d
Cleared May 18, 1994
KIRSCHNER ZIRCONIA FEMORAL HEAD
K934694 · LZO
Kirschner Medical Corp.
Orthopedic · 230d
Cleared May 18, 1994
FLEXSURE HP
K934863 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 218d
Cleared May 18, 1994
SONIPLAK
K935150 · JEQ
American Dentronics, Inc.
Dental · 202d
Cleared May 18, 1994
NITINOL, NITI
K935638 · DZC
Highland Metals
Dental · 176d
Cleared May 18, 1994
LAPAROSCOPIC/SUCTION/IRRIGATION PROBE
K935826 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 163d
Cleared May 18, 1994
COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG)
K935866 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 166d
Cleared May 18, 1994
ARTHROSCOPES AND ACCESSORIES
K936213 · HRX
Micro-Medical Devices, Inc.
Orthopedic · 140d
Cleared May 18, 1994
MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
K940011 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 134d
Cleared May 18, 1994
NPH-KLENZ
K940263 · FLG
Calgon Corp.
General Hospital · 117d
Cleared May 18, 1994
AMIGO J-9
K940334 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 113d
Cleared May 18, 1994
MICROCOAGULATION PROTHROMBIN TIME TEST
K940432 · GJS
International Technidyne Corp.
Hematology · 107d
Cleared May 18, 1994
GORE-TEX CARDIOVASCULAR PATCH
K940906 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 83d
Cleared May 18, 1994
NON-PRESCRIPTION SUNGLASSES
K940958 · HQY
Great Future Works , Ltd.
Ophthalmic · 78d