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
103489–103512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1995
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
K951201 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 06, 1995
MODIFIED BIOPSY NEEDLE
K951229 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 17d
Cleared Apr 06, 1995
HYBRID SURGICAL DEVICES, MODIFICIATION
K951353 · GEI
Laser Centers of America, Inc.
General & Plastic Surgery · 38d
Cleared Apr 05, 1995
OLYMPUS PBD STENTS
K933200 · FGE
Olympus Corp.
Gastroenterology & Urology · 643d
Cleared Apr 05, 1995
CHEMILUMINESCENCE LH
K935319 · CEP
Nichols Institute Diagnostics
Chemistry · 532d
Cleared Apr 05, 1995
HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES
K936056 · KHE
Dipro Diagnostic Products GmbH
Hematology · 471d
Cleared Apr 05, 1995
DV TEST AND DVV CONFIRM
K940490 · GIR
American Diagnostica, Inc.
Hematology · 426d
Cleared Apr 05, 1995
PREMIER PROMAX BITE GUARD
K941856 · JXL
Premier Dental Products Co.
Neurology · 355d
Cleared Apr 05, 1995
PYLORISET DRY
K942974 · LYR
Orion Diagnostica, Div. Orion Corp.
Microbiology · 289d
Cleared Apr 05, 1995
CATCO UMBILICAL VESSEL CATHETER
K944336 · FOZ
Catco Medical, Inc.
General Hospital · 211d
Cleared Apr 05, 1995
CATCO POLYURETHANE UMBILICAL VESSEL CATHETER
K944367 · FOZ
Catco Medical, Inc.
General Hospital · 210d
Cleared Apr 05, 1995
CATCO SILICONE UMBILICAL VESSEL CATHETER
K944368 · FOZ
Catco Medical, Inc.
General Hospital · 210d
Cleared Apr 05, 1995
CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER
K944410 · FOZ
Catco Medical, Inc.
General Hospital · 209d
Cleared Apr 05, 1995
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
K944614 · FDX
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 197d
Cleared Apr 05, 1995
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · KXS
Roche Diagnostic Systems, Inc.
Toxicology · 163d
Cleared Apr 05, 1995
GALAXY MD SERIES THERAPYPOOLS
K945824 · BXB
Galaxy Aquatics, Inc.
Physical Medicine · 127d
Cleared Apr 05, 1995
IRISPEC URINE CHEMISTRY CONTROL PART A AND B
K945913 · JJW
International Remote Imaging Systems
Chemistry · 124d
Cleared Apr 05, 1995
AVL OMNI ANALYZER
K945915 · JJC
Avl Scientific Corp.
Chemistry · 124d
Cleared Apr 05, 1995
CONSENSUS(TM) PATELLA REAMER
K946197 · HWE
U.S. Medical Products, Inc.
Orthopedic · 106d
Cleared Apr 05, 1995
PROVIDENT HP SYSTEM
K946371 · JDI
Stelkast Company
Orthopedic · 120d
Cleared Apr 05, 1995
MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER
K950026 · DQY
Medtronics Interventional Vascular
Cardiovascular · 91d
Cleared Apr 05, 1995
SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER
K950047 · DQY
Isomedix Operations, Inc.
Cardiovascular · 90d
Cleared Apr 05, 1995
PINWORM EGG COLLECTOR
K950096 · LIO
Evergreen Industries, Inc.
Microbiology · 85d
Cleared Apr 05, 1995
PERSYST SPIKE DETECTOR
K950117 · OMB
Persyst Consulting Services, Inc.
Neurology · 84d