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
121801–121824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1991
STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED
K905850 · LJT
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED
K905852 · LJT
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
ULTRA-SELECT PTCA GUIDEWIRE
K910280 · DQX
Microvena Corp.
Cardiovascular · 86d
Cleared Apr 19, 1991
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
K910377 · GCX
CooperSurgical, Inc.
General Hospital · 80d
Cleared Apr 19, 1991
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · BSS
Sherwood Medical Co.
Gastroenterology & Urology · 72d
Cleared Apr 19, 1991
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
K910486 · LJS
Davol, Inc.
General Hospital · 72d
Cleared Apr 19, 1991
MOSS GASTROSTOMY TUBE
K910913 · KNT
Moss Medical Products
Gastroenterology & Urology · 45d
Cleared Apr 19, 1991
A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT
K911055 · LJT
Therex Corp.
General Hospital · 42d
Cleared Apr 19, 1991
FORCEPS, COAGULATION, BIPOLAR, MALIS
K911377 · GEI
International Hospital Supply Co.
General & Plastic Surgery · 22d
Cleared Apr 19, 1991
CUSTOM PERSONAL EAR - CPE
K911497 · ESD
Qualitone
Ear, Nose, Throat · 18d
Cleared Apr 19, 1991
ADJUSTRETTE - DAO, MODIFICATION
K911498 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ELEGANCE - DEO, MODIFICATION
K911499 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ULTRA & ULTRA LITE II, MODIFICATION
K911504 · ESD
Qualitone
Ear, Nose, Throat · 16d
Cleared Apr 18, 1991
PATHWAY II ELECTROMYOGRAPH
K897132 · HCC
The Prometheus Group
Neurology · 477d
Cleared Apr 18, 1991
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER
K904783 · JJQ
Industrial Chemical Measurement
Chemistry · 178d
Cleared Apr 18, 1991
PLANMED SOPHIE
K904953 · IZH
Planmeca USA, Inc.
Radiology · 164d
Cleared Apr 18, 1991
IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES
K905236 · NHJ
Percussionaire Corp.
Anesthesiology · 162d
Cleared Apr 18, 1991
URESIL VALVE CUTTER
K905528 · DWQ
Uresil Corp.
Cardiovascular · 129d
Cleared Apr 18, 1991
LEEP REDIKIT
K910253 · HEE
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Apr 18, 1991
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
K910254 · HHE
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Apr 18, 1991
SCHNEIDER MAGNARAIL PROBING CATHETER
K910259 · DQO
Schneider Intl., Ltd.
Cardiovascular · 86d
Cleared Apr 18, 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 85d
Cleared Apr 18, 1991
SYSTEM 7300 PULSE OXIMETER
K910521 · DQA
Advanced Medical Instruments, Inc.
Anesthesiology · 70d
Cleared Apr 18, 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · DTD
Medtronic Vascular
Cardiovascular · 64d