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
89833–89856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1998
SCION BALLOON ELEVATOR
K973698 · GCJ
Scion International, Inc.
General & Plastic Surgery · 186d
Cleared Mar 31, 1998
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE...
K974493 · FDS
Fiegert-Endotech Medizintechnik GmbH
Gastroenterology & Urology · 123d
Cleared Mar 31, 1998
UROMED PATCH
K974600 · MNG
Uromed Corp.
Gastroenterology & Urology · 112d
Cleared Mar 31, 1998
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 90d
Cleared Mar 31, 1998
PEREGRINE TAPERED DIFFUSION PROBE
K980025 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Mar 31, 1998
PEREGRINE SHIELDED DIFFUSION PROBE
K980027 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Mar 31, 1998
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
K980919 · EZL
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 20d
Cleared Mar 30, 1998
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
K972992 · CCL
Ceramatec, Inc.
Anesthesiology · 230d
Cleared Mar 30, 1998
SILGEL TOPICAL GEL SHEET
K974172 · MDA
Nagor , Ltd.
General & Plastic Surgery · 145d
Cleared Mar 30, 1998
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K974210 · MOT
Rad-Source, Inc.
Radiology · 140d
Cleared Mar 30, 1998
FLOSI RIGID GAS PERMEABLE CONTACT LENS
K974636 · HQD
Futuristic Design Assoc.
Ophthalmic · 108d
Cleared Mar 30, 1998
JMS APHERESIS NEEDLE
K974902 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 30, 1998
CARESIDE CREATININE
K980043 · JFY
Exigent Diagnostics, Inc.
Chemistry · 83d
Cleared Mar 30, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K980114 · LNH
GE Medical Systems
Radiology · 76d
Cleared Mar 30, 1998
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL,...
K980818 · LPL
Stephen A. Dunn, Inc.
Ophthalmic · 27d
Cleared Mar 27, 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919 · HWC
Bionx Implants, Inc.
Orthopedic · 232d
Cleared Mar 27, 1998
DUOCLIPPER TITANIUM CLIPS
K973652 · FZP
Scion International, Inc.
General & Plastic Surgery · 183d
Cleared Mar 27, 1998
KMC NEWSKIN
K974143 · MDA
Kmc Intl. Co.
General & Plastic Surgery · 144d
Cleared Mar 27, 1998
PHORESOR II, MODEL PM900
K974855 · KTB
Iomed, Inc.
Physical Medicine · 88d
Cleared Mar 27, 1998
CRANEX TOME CEPH, OR CRANEX TOME
K974877 · EHD
Orion Corporation Soredex
Radiology · 88d
Cleared Mar 27, 1998
E3 MICROPROBE
K974878 · GEX
Martin Uram, MD
General & Plastic Surgery · 87d
Cleared Mar 27, 1998
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES
K974896 · GEX
Laserscope
General & Plastic Surgery · 86d
Cleared Mar 27, 1998
SOFSILK SUTURE
K980124 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 72d
Cleared Mar 27, 1998
DRUG CHECK
K980153 · DIO
Texas Immunology, Inc.
Toxicology · 70d