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
106177–106200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1994
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
K934366 · HWC
Mitek Surgical Products, Inc.
Orthopedic · 395d
Cleared Oct 07, 1994
GALILEO ARTHROSCOPES
K934707 · HRX
Galileo Electro-Optics Corp.
Orthopedic · 372d
Cleared Oct 07, 1994
NORTA
K935630 · EZL
Beiersdorf, Inc.
Gastroenterology & Urology · 318d
Cleared Oct 07, 1994
3M FLUID IRRIGATION SYSTEM
K941388 · HRX
3M Healthcare
Orthopedic · 199d
Cleared Oct 07, 1994
3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD
K941718 · HRX
3M Medical Products Group
Orthopedic · 183d
Cleared Oct 07, 1994
SPECIALTY ASSAYED CONTROL-1
K941737 · GIZ
Helena Laboratories
Hematology · 183d
Cleared Oct 07, 1994
VIROTROL TORCH
K942295 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 148d
Cleared Oct 07, 1994
1.2 MICRON AIR ELIMINATING FILTER
K942625 · FPB
The Medi-Dose Group
General Hospital · 127d
Cleared Oct 07, 1994
ENSURE POWDER-FREE LATEX PATIENT EXAMINATION GLOVES
K942643 · LYY
Basic Intl., Inc.
General Hospital · 126d
Cleared Oct 07, 1994
NORELCO CLEAN AIR SYSTEM MODEL CAM665
K942686 · FRF
Norelco Consumer Products Co.
General Hospital · 122d
Cleared Oct 07, 1994
CBC-LINE HEMATOLOGY LINEARITY CONTROL
K942822 · JPK
R&D Systems, Inc.
Hematology · 114d
Cleared Oct 07, 1994
EXAMINATION GLOVES
K942877 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 112d
Cleared Oct 07, 1994
URINARY CATECHOLAMINE KIT
K943099 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 100d
Cleared Oct 07, 1994
MAUNAL DISPOSABLE DENTAL INSTRUMENTS
K943351 · EKJ
Magnum Instruments, Inc.
Dental · 87d
Cleared Oct 07, 1994
UNIGRIP
K943502 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 93d
Cleared Oct 07, 1994
BILL EVANS-KLENZ
K944033 · FLG
Calgon Vestal Div.
General Hospital · 51d
Cleared Oct 07, 1994
THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS
K944091 · GEX
Lca, Inc.
General & Plastic Surgery · 46d
Cleared Oct 07, 1994
KARL STORZ INSULATED SCISSORS AND RECTAL SNARES
K944530 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 23d
Cleared Oct 07, 1994
ISOLATED CAMERA HEAD
K944707 · FWF
Envision Medical Corp.
General & Plastic Surgery · 14d
Cleared Oct 07, 1994
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · KNY
Boston Scientific Corp
Gastroenterology & Urology · 11d
Cleared Oct 06, 1994
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K935452 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 328d
Cleared Oct 06, 1994
COMET CAPNOGRAPH MODULE
K941165 · CCK
Spacelabs, Inc.
Anesthesiology · 209d
Cleared Oct 06, 1994
VITAFLON PLUS/VASCULON
K941417 · FOZ
Hogan & Hartson
General Hospital · 197d
Cleared Oct 06, 1994
APR ACETABULAR INSERT
K941617 · JDI
Intermedics Orthopedics
Orthopedic · 185d