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
93313–93336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1997
ULTRAVERSE PTA CATHETER
K964881 · LIT
Vas-Cath, Inc.
Cardiovascular · 174d
Cleared May 28, 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 106d
Cleared May 28, 1997
EARCHECK PRO
K970685 · ETY
Mdi Instruments, Inc.
Ear, Nose, Throat · 93d
Cleared May 28, 1997
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES
K970797 · GEI
Olympus America, Inc.
General & Plastic Surgery · 85d
Cleared May 28, 1997
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
K970828 · ESD
United Hearing Systems, Inc.
Ear, Nose, Throat · 83d
Cleared May 28, 1997
Cordis Endeavor Infusion Catheter
K970842 · QEY
Cordis Corp.
Cardiovascular · 82d
Cleared May 28, 1997
USCI MAINSTAY GUIDING CATHETER
K971034 · DQO
C.R. Bard, Inc.
Cardiovascular · 68d
Cleared May 28, 1997
KASHA VISUAL FIELD SYSTEM
K971156 · HPT
Kasha Software, Inc.
Ophthalmic · 61d
Cleared May 28, 1997
DURALASTIC I AND DURALASTIC II
K971480 · MIB
Allied Biomedical Corp.
General & Plastic Surgery · 35d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · HWE
Synthes (Usa)
Orthopedic · 30d
Cleared May 27, 1997
KSEA CO2 ENDOFLATOR
K963423 · HIF
Karl Storz Endoscopy
Obstetrics & Gynecology · 270d
Cleared May 27, 1997
ORTHOCHUCK
K964252 · GEY
Buckman Co., Inc.
General & Plastic Surgery · 215d
Cleared May 27, 1997
CYBERJET LOCAL ANESTHESIA SYSTEM
K964802 · EGM
Intra Vantage, Inc.
Dental · 179d
Cleared May 27, 1997
CONVERTORS SMS DRAPES
K970554 · KKX
Allegiance Healthcare Corp.
General Hospital · 103d
Cleared May 27, 1997
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K970718 · JNM
R&D Systems, Inc.
Immunology · 90d
Cleared May 27, 1997
LIFECORE O-RING ABUTMENT
K970776 · DZE
Lifecore Biomedical, Inc.
Dental · 84d
Cleared May 27, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)
K970786 · MRZ
Alexander Mfg. Co.
General Hospital · 84d
Cleared May 27, 1997
NON-STERILE ISOLATION GOWN
K970814 · FYC
American Seal Co.
General Hospital · 82d
Cleared May 27, 1997
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY,...
K971202 · OCZ
Comeg Endoskopie GmbH
Gastroenterology & Urology · 56d
Cleared May 27, 1997
LSVP INTERNATIONAL HOT BIOPSY FORCEPS
K971204 · KGE
Lsvp Intl., Inc.
Gastroenterology & Urology · 56d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018
K971212 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
K971213 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825
K971234 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
K971237 · MRZ
Alexander Mfg. Co.
General Hospital · 55d