FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90337–90360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1998
HTL MALE CONDOM
K980019 · HIS
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 89d
Cleared Apr 01, 1998
ENDOBUTTON CONTINUOUS LOOP
K980155 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Apr 01, 1998
LIGHTSOURCE OR ILLUMINATOR
K980166 · HET
Cuda Products Co.
Obstetrics & Gynecology · 75d
Cleared Apr 01, 1998
AEROSET SYSTEM
K980367 · CGZ
Abbott Laboratories
Chemistry · 62d
Cleared Apr 01, 1998
SABRE BT BLUNT0TIP SURGICAL TROCAR
K980804 · FBQ
Endoscopic Concepts, Inc.
General & Plastic Surgery · 30d
Cleared Apr 01, 1998
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071,...
K980865 · DKZ
Phamatech
Toxicology · 26d
Cleared Mar 31, 1998
CHASE FEMORAL ACCESS CANNULATION SET
K972993 · DWF
Chase Medical, Inc.
Cardiovascular · 231d
Cleared Mar 31, 1998
CARDIO-PAGER SYSTEM
K973527 · MSX
Data Critical Corp.
Cardiovascular · 194d
Cleared Mar 31, 1998
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K973684 · HAW
Elekta Instrument AB
Neurology · 186d
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