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
103993–104016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1995
MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM
K941534 · KWY
3M Health Care, Ltd.
Orthopedic · 341d
Cleared Mar 06, 1995
FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
K941692 · EZL
Rochester Medical Corp.
Gastroenterology & Urology · 334d
Cleared Mar 06, 1995
DIASTAT ANTI-PR3 (C-ANCA) KIT
K942813 · MOB
Shield Diagnostics, Ltd.
Immunology · 265d
Cleared Mar 06, 1995
DIASTAT ANTI-MPO (PANCA) KIT
K943630 · MOB
Shield Diagnostics, Ltd.
Immunology · 223d
Cleared Mar 06, 1995
USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM
K943638 · GEX
United States Dental Laser, Inc.
General & Plastic Surgery · 222d
Cleared Mar 06, 1995
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
K943768 · DHB
Diagnostic Products Corp.
Immunology · 216d
Cleared Mar 06, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K943774 · LZO
Osteonics Corp.
Orthopedic · 216d
Cleared Mar 06, 1995
MANUAL INSTRUMENTS
K943937 · HRX
Pantheon Surgical Products
Orthopedic · 206d
Cleared Mar 06, 1995
RESTORATION HA ACETABULAR CUP SERIES
K943957 · MEH
Osteonics Corp.
Orthopedic · 203d
Cleared Mar 06, 1995
ONYX
K943967 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Mar 06, 1995
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
K944191 · DBL
Light Diagnostics
Immunology · 189d
Cleared Mar 06, 1995
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER
K944192 · DBL
Light Diagnostics
Immunology · 189d
Cleared Mar 06, 1995
RECHARGEABLE BATTERIES
K944521 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 171d
Cleared Mar 06, 1995
TRANSTYMPANIC ENDOSCOPE
K945081 · EOB
Endooptiks, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 06, 1995
MITEK THRADED ANCHOR (MTA)
K945203 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 132d
Cleared Mar 06, 1995
PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS
K945209 · GCF
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 132d
Cleared Mar 06, 1995
PRO BARRIER(TM) TUBE SOX(TM)
K945575 · MMN
Cottrell, Ltd.
General Hospital · 112d
Cleared Mar 06, 1995
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT
K945613 · HSX
Howmedica Corp.
Orthopedic · 111d
Cleared Mar 06, 1995
R&D PART NOS. 5262, 5543, 5432, 5469
K945868 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 95d
Cleared Mar 06, 1995
NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT...
K946089 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 83d
Cleared Mar 06, 1995
QUADRA-COIL URETERAL STENT
K946296 · FAD
Surgitek
Gastroenterology & Urology · 69d
Cleared Mar 06, 1995
MODULAR BIOPSY FORCEP
K946360 · FCL
Cox Medical Ent., Inc.
Gastroenterology & Urology · 66d
Cleared Mar 06, 1995
HUMAN PROTEIN C RID TEST KIT
K950015 · GGP
Jay H. Geller
Microbiology · 62d
Cleared Mar 06, 1995
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
K950027 · JDQ
Intermedics Orthopedics
Orthopedic · 61d