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
150193–150216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1984
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
K844417 · GAG
Davis & Geck, Inc.
General & Plastic Surgery · 32d
Cleared Dec 17, 1984
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
K844420 · BTM
Med-Life, Inc.
Anesthesiology · 32d
Cleared Dec 17, 1984
MEDIPART XENON BREATHING KIT MP-02XM
K844495 · IYT
Medipart Jerry Alexander
Radiology · 27d
Cleared Dec 17, 1984
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE
K844557 · BSR
Ackrad Laboratories
Anesthesiology · 26d
Cleared Dec 17, 1984
ACUTE HEMODIALYSIS TRAYS
K844612 · KNZ
Packaging Technologies, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 17, 1984
TUBING HOLDER
K844757
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 10d
Cleared Dec 14, 1984
STAPLE REMOVER SR300P
K833085 · GDT
Prosper, Inc.
General & Plastic Surgery · 459d
Cleared Dec 14, 1984
MYOPULSE
K833928 · IPF
Biomedical Design Instruments
Physical Medicine · 396d
Cleared Dec 14, 1984
BIPOLAR SUCTION ELECTRODE
K843498 · GET
Eder Instrument Co, Inc.
General & Plastic Surgery · 99d
Cleared Dec 14, 1984
MONTGOMERY SAFE-T-TUBE
K843936 · BTR
Boston Medical Products, Inc.
Anesthesiology · 66d
Cleared Dec 14, 1984
CONCEP-7-BHCG (EIA)
K844153 · JHI
Leeco Diagnostics, Inc.
Chemistry · 51d
Cleared Dec 14, 1984
API UNISCEPT MIC 100UL
K844159 · LTW
Analytical Products, Inc.
Microbiology · 51d
Cleared Dec 14, 1984
DIAGONAL PIN CUTTER
K844599
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Dec 14, 1984
SLIP JOINT PLIERS
K844600 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Dec 14, 1984
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
K844628 · GAG
American V. Mueller
General & Plastic Surgery · 17d
Cleared Dec 13, 1984
LASERSPEC
K841430
Clement Clarke, Inc.
Ophthalmic · 251d
Cleared Dec 13, 1984
PHILIPS SDR 1200
K842900 · IYO
Philips Medical Systems, Inc.
Radiology · 143d
Cleared Dec 13, 1984
CIVCO-SUPER SCAN/BIOPSY GUIDE
K843573 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 93d
Cleared Dec 13, 1984
DRY TRAY
K843782 · EFQ
E.M. Adams
General & Plastic Surgery · 78d
Cleared Dec 13, 1984
ULTRA & ULTRA MINATURE
K843789 · ESD
Qualitone
Ear, Nose, Throat · 77d
Cleared Dec 13, 1984
STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN
K843883
Applied Medical Devices, Inc.
General & Plastic Surgery · 72d
Cleared Dec 13, 1984
GENERAL UTILITY TRAY SYSTEM
K843884
Applied Medical Devices, Inc.
General & Plastic Surgery · 72d
Cleared Dec 13, 1984
PYRIDOXAL DISC
K844020 · JTO
Remel Co.
Microbiology · 59d
Cleared Dec 13, 1984
E-COLI-CHEK TUBE
K844276 · JTO
E-Y Laboratories, Inc.
Microbiology · 38d