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
110209–110232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1994
COMBI 2.5 INTERSEGMENTAL TRACTION TABLE
K933443 · JFB
Williams Healthcare Systems, LLC
Physical Medicine · 203d
Cleared Feb 02, 1994
WINDMERE MASSAGE MATE
K933974 · IRO
Windmere Corp.
Physical Medicine · 173d
Cleared Feb 02, 1994
PARTNERS LATEX EXAM GLOVES PLUS MULTIPLE NAMES
K934408 · LYY
Sjs Supreme, Inc.
General Hospital · 146d
Cleared Feb 02, 1994
KACEY DISPOSABLE INFANT HEEL WARMER
K934673 · IMD
K & C Medical, Inc.
Physical Medicine · 125d
Cleared Feb 02, 1994
LOW AIR LOSS MATTRESS, MODIFICATION
K934689 · INX
Cardio Systems, Inc.
Physical Medicine · 163d
Cleared Feb 02, 1994
MULTI-COMFORT POWDER FREE
K935033 · LYY
Perusahaan Intan Emas Sdn. Bhd.
General Hospital · 105d
Cleared Feb 02, 1994
WALK N CHAIR
K935211 · IOR
Brookefield Hunter, Inc.
Physical Medicine · 96d
Cleared Feb 02, 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271 · IMG
Chattanooga Group, Inc.
Physical Medicine · 92d
Cleared Feb 02, 1994
HYDRODERM BREATHABLE TRANSPARENT DRESSING
K935796 · MGP
Wilshire Medical Products
General & Plastic Surgery · 57d
Cleared Feb 02, 1994
SURGICAL SPONGE X-RAY DETECTABLE
K935993 · GDY
Mcneil Healthcare, Inc.
General & Plastic Surgery · 51d
Cleared Feb 02, 1994
GAUZE SPONGE
K936095 · EFQ
Dukal Corp.
General & Plastic Surgery · 42d
Cleared Feb 02, 1994
REGENCY TUBE
K936243 · DZD
Ortho Specialties
Dental · 34d
Cleared Feb 02, 1994
REGENCY BRACKET
K936244 · EJF
Mid-American Dental Specialties, Inc.
Dental · 34d
Cleared Feb 01, 1994
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · JEY
Aesculap, Inc.
Dental · 557d
Cleared Feb 01, 1994
QUEST HEART INSULATION PAD
K925049 · DWF
Quest Medical, Inc.
Cardiovascular · 483d
Cleared Feb 01, 1994
ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK
K925496 · FRC
Pymah Corp.
General Hospital · 459d
Cleared Feb 01, 1994
ATI(R) DISP BIOLOGICAL-PLUS TEST PACK
K925745 · FRC
Pymah Corp.
General Hospital · 445d
Cleared Feb 01, 1994
TECHMEDICA STANDARD CEMENTED HIP SYSTEM
K926387 · KWY
Techmedica, Inc.
Orthopedic · 406d
Cleared Feb 01, 1994
PROFAST - DENTURE ADHESIVE FOR LOWER JAWS
K930335 · KOO
Fittydent-Altwirth & Schmitt GmbH
Dental · 375d
Cleared Feb 01, 1994
AME(R) RIGID FIXATION SYSTEM
K930531 · KWP
American Medical Electronics, Inc.
Orthopedic · 364d
Cleared Feb 01, 1994
REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
K930571 · HFI
Numed Technologies, Inc.
Obstetrics & Gynecology · 362d
Cleared Feb 01, 1994
ALPHA-DENT ROOT CANAL SEALER
K930872 · KIF
Wallace A. Erickson & Co.
Dental · 347d
Cleared Feb 01, 1994
EZ GRIP REUSABLE TENS/NMES ELECTRODES
K931108 · GZJ
Advanced Adhesives
Neurology · 335d
Cleared Feb 01, 1994
IL TEST CALCIUM
K931362 · CIC
Instrumentation Laboratory CO
Chemistry · 321d