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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,820 results
98161–98184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1996
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
K960173 · FAT
Gabriel Medical, Inc.
Gastroenterology & Urology · 163d
Cleared Jun 27, 1996
INDEX SHOE
K960307 · IRN
Orthopedic Technology Research, Inc.
Physical Medicine · 157d
Cleared Jun 27, 1996
ACCUMETER H. PYLORI TEST
K960478 · LYR
Chemtrak, Inc.
Microbiology · 146d
Cleared Jun 27, 1996
LIBERTY LITE PFS SYSTEM
K960496 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 147d
Cleared Jun 27, 1996
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
K960746 · LYZ
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 125d
Cleared Jun 27, 1996
EASTERCLAVE
K961230 · FLE
Easter Services, Inc.
General Hospital · 90d
Cleared Jun 27, 1996
PUNCTUR-GUARD WINGED SET
K961251 · FMI
Bio-Plexus, Inc.
General Hospital · 87d
Cleared Jun 27, 1996
PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
K961267 · JDQ
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Jun 27, 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271 · DQX
C.R. Bard, Inc.
Cardiovascular · 86d
Cleared Jun 27, 1996
DELTATALKER WITH INFRARED
K961306 · IQA
Prentke Romich Co.
Physical Medicine · 84d
Cleared Jun 27, 1996
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
K961310 · HQC
Storz Instrument Co.
Ophthalmic · 84d
Cleared Jun 27, 1996
MX960 REUSABLE PRESSURE TRANSDUCER
K961404 · DRS
Medex, Inc.
Cardiovascular · 77d
Cleared Jun 27, 1996
CEDIA THEOPHYLLINE ASSAY
K961462 · KLS
Boehringer Mannheim Corp.
Toxicology · 71d
Cleared Jun 27, 1996
LASER PERIPHERALS INC. BARE FIBER
K961516 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 66d
Cleared Jun 27, 1996
CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
K961690 · JAA
Continental X-Ray Corp.
Radiology · 57d
Cleared Jun 27, 1996
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
K961840 · BTR
Rusch Intl.
Anesthesiology · 45d
Cleared Jun 27, 1996
SHARPS-TAINER
K961878 · FMI
Winfield Industries
General Hospital · 43d
Cleared Jun 26, 1996
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
K942867 · KPL
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 740d
Cleared Jun 26, 1996
THERMACYL BLOOD/FLUID WARMER
K953741 · BSB
Baxter Healthcare Corp
Hematology · 321d
Cleared Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572 · BZD
Respironics, Inc.
Anesthesiology · 268d
Cleared Jun 26, 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · DHR
Randox Laboratories, Ltd.
Immunology · 93d
Cleared Jun 26, 1996
EVRON GEL
K961222 · KMJ
Pharmaceutical Innovations, Inc.
Radiology · 90d
Cleared Jun 26, 1996
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER...
K961232 · DQX
Biocompatibles , Ltd.
Cardiovascular · 89d
Cleared Jun 26, 1996
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
K961295 · GBX
Sil-Med Corp.
General & Plastic Surgery · 83d