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
163129–163152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1981
OCCLUSION CATHETER
K811276 · DYG
Bionomy, Inc.
Cardiovascular · 53d
Cleared Jun 30, 1981
MODEL 5866-24 LEAD ADAPTOR KIT
K811349 · DTD
Medtronic Vascular
Cardiovascular · 48d
Cleared Jun 30, 1981
TELETRACE TELEPHONE EKG SYSTEM
K811512 · DXH
Medtronic Vascular
Cardiovascular · 33d
Cleared Jun 30, 1981
NORELCO ANEROID BLOOD PRESSURE METER
K811634 · DXQ
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
NORELCO DIGITAL BLOOD PRESSURE METER
K811635 · DXN
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
NORELCO ELECTRONIC BLOOD PRESSURE METER
K811636 · DXN
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
I.V. ADMINISTRATION SET
K811685 · FPA
Quest Medical, Inc.
General Hospital · 15d
Cleared Jun 29, 1981
ECCO GENERATOR
K811198 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 60d
Cleared Jun 26, 1981
SUCTION WOUND DRAINAGE DEVICE
K810739 · KQT
The Urology Group
Gastroenterology & Urology · 99d
Cleared Jun 26, 1981
SUMMAR NON-PRECIOUS, CERAMIC ALLOY
K811013 · EJH
Shofu Dental Corp.
Dental · 72d
Cleared Jun 26, 1981
SKIN SCRUB TRAY
K811287
Associated Medical Products Co.
General & Plastic Surgery · 49d
Cleared Jun 26, 1981
SPETZLER LUMBAR-PERITONEAL SYSTEM
K811288 · JXG
American Heyer Schulte
Neurology · 46d
Cleared Jun 26, 1981
SONUS V
K811396 · ELC
California Technics, Inc.
Dental · 39d
Cleared Jun 26, 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Jun 26, 1981
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · BTO
Shiley, Inc.
Anesthesiology · 35d
Cleared Jun 26, 1981
K-FLEX
K811519
Sybron Corp.
Dental · 29d
Cleared Jun 26, 1981
FUJI IONOMER TYPE I & II
K811521 · EMA
G-C Intl. Corp.
Dental · 28d
Cleared Jun 26, 1981
RE-HP SERIES HEARING AIDS
K811522 · ESD
Radioear Corp.
Ear, Nose, Throat · 28d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69S
K811529 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB 69 T
K811530 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69
K811531 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
LO-VOL I.V. SETS
K811561 · FPA
Sea Medical Products, Inc.
General Hospital · 23d
Cleared Jun 26, 1981
GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET
K811580 · FFL
Porges Catheter Corp.
Gastroenterology & Urology · 21d
Cleared Jun 26, 1981
VISIO-SEAL
K811624 · EBC
Espe-Premier Sales Co.
Dental · 17d