FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77305–77328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2001
APPLIED ACCESS SEAL
K012968 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · HWC
Synthes (Usa)
Orthopedic · 84d
Cleared Dec 03, 2001
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB...
K013231 · BSP
Avid N.I.T., Inc.
Anesthesiology · 67d
Cleared Dec 03, 2001
NIPRO SAFELET CATH
K013287 · FOZ
Nipro Medical Corp.
General Hospital · 62d
Cleared Dec 03, 2001
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND...
K013288 · LYY
Sgmp Co., Ltd.
General Hospital · 62d
Cleared Dec 03, 2001
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
K013328 · IMC
Remington Products Company, LLC
Physical Medicine · 59d
Cleared Dec 03, 2001
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · NEU
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 49d
Cleared Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · FPA
Sterling Medivations, Inc.
General Hospital · 42d
Cleared Dec 03, 2001
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT...
K013624 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Dec 03, 2001
XPLAN 2.2 WITH THE BODY SYSTEM
K013661 · MUJ
Radionics, A Division of Tyco...
Radiology · 27d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772 · LXT
Howmedica Osteonics
Orthopedic · 20d
Cleared Dec 03, 2001
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
K013849 · ITX
Tetrad Corp.
Radiology · 13d
Cleared Dec 03, 2001
PAIN CARE 3200
K013928 · MEB
Breg, Inc.
General Hospital · 5d
Cleared Nov 30, 2001
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043 · JXA
Osmetech
Microbiology · 239d
Cleared Nov 30, 2001
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA...
K011479 · CGA
Inverness Medical Innovations, Inc.
Chemistry · 200d
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · PSZ
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Nov 30, 2001
SERIM BLOOD LEAK TEST STRIP-2
K012115 · FJD
Serim Research Corp.
Gastroenterology & Urology · 147d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K012483 · DJG
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
K012484 · DKZ
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · GTZ
Binax, Inc.
Microbiology · 116d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN PCP
K012582 · LCM
Ameditech, Inc.
Toxicology · 112d
Cleared Nov 30, 2001
GIOTTO IMAGE
K012953 · IZH
Medx, Inc.
Radiology · 87d
Cleared Nov 30, 2001
LYMPHA PRESS PLUS DEVICE
K013331 · JOW
Mego Afek
Cardiovascular · 56d