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
106249–106272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1994
HYDROTRACK
K935509 · BXB
Ferno Ille
Physical Medicine · 322d
Cleared Oct 03, 1994
S-ROM NOILES CRUCIATE RETAINING KNEE
K936037 · JWH
Joint Medical Products Corp.
Orthopedic · 287d
Cleared Oct 03, 1994
CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
K940249 · LRR
Certified Safety Mfg., Inc.
General & Plastic Surgery · 257d
Cleared Oct 03, 1994
WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
K940396 · ESW
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 249d
Cleared Oct 03, 1994
BAND-AID(TM) BRAND ADHESIVE BANDAGE
K940536 · KGX
Johnson & Johnson Consumer Products,...
General & Plastic Surgery · 238d
Cleared Oct 03, 1994
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
K941048 · LXT
Applied Osteo Systems, Inc.
Orthopedic · 210d
Cleared Oct 03, 1994
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
K941146 · JLW
Dupont Medical Products
Chemistry · 207d
Cleared Oct 03, 1994
LIFESHIELD EXTENSION SET
K941214 · FPK
Abbott Mfg., Inc.
General Hospital · 207d
Cleared Oct 03, 1994
K-WIRES AND STEINMANN PINS
K941434 · HTY
Omega Surgical Instruments, Inc.
Orthopedic · 193d
Cleared Oct 03, 1994
DISPOSABLE EMERGENCY OBSTETRICAL KIT
K941641 · KNA
Gam Industries, Inc.
Obstetrics & Gynecology · 182d
Cleared Oct 03, 1994
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP
K941788 · KGX
Johnson & Johnson Consumer Products,...
General & Plastic Surgery · 175d
Cleared Oct 03, 1994
SUNGLASSES
K942011 · HQY
Shanghai Gopher Arts & Crafts Co., Ltd.
Ophthalmic · 160d
Cleared Oct 03, 1994
MSV-2000 VIDEO IMAGING SYSTEM
K942924 · GCJ
Del Medical Systems Corp.
General & Plastic Surgery · 103d
Cleared Oct 03, 1994
CUSH ISLAND DRESSING
K943424 · MGP
Cush Medical Products
General & Plastic Surgery · 80d
Cleared Oct 03, 1994
CURADERM ALGINATE HYDROCOLLOID
K943636 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 68d
Cleared Oct 03, 1994
BEHRING NEPHELOMETER II
K943997 · DEW
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Oct 03, 1994
CHIBA STYLE BIOPSY NEEDLE
K944044 · LRO
Kormed, Inc.
General & Plastic Surgery · 46d
Cleared Oct 03, 1994
DISPOSABLE, PREFORMED FACE MASK
K944157 · BSJ
Meridian Medical Systems, Inc.
Anesthesiology · 38d
Cleared Oct 03, 1994
SUNGLASSES
K944281 · HQY
Sun Glory Optic CO , Ltd.
Ophthalmic · 31d
Cleared Oct 03, 1994
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288 · DCK
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared Oct 03, 1994
TONKA BOYS SUNGLASSES
K944328 · HQY
Hasbro Industries, Inc.
Ophthalmic · 27d
Cleared Oct 03, 1994
O-R-EZ TIP CLEANER
K944370 · GEI
O-R-Ez, Inc.
General & Plastic Surgery · 26d
Cleared Oct 03, 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · DCK
Behring Diagnostics, Inc.
Immunology · 26d
Cleared Oct 03, 1994
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
K944467 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 24d