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
87625–87648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1998
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
K983478 · HEB
Organic Essentials
Obstetrics & Gynecology · 38d
Cleared Nov 06, 1998
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
K973585 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 410d
Cleared Nov 06, 1998
ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
K980895 · LFL
California Institute of Tissue Eng. &...
General & Plastic Surgery · 242d
Cleared Nov 06, 1998
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
K980999 · JWH
Instrument Makar, Inc.
Orthopedic · 233d
Cleared Nov 06, 1998
QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS...
K981462 · ITI
Sunrise Medical, Inc.
Physical Medicine · 197d
Cleared Nov 06, 1998
ACE ALVEOLAR DISTRACTOR
K981526 · JEY
Ace Surgical Supply Co., Inc.
Dental · 192d
Cleared Nov 06, 1998
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL...
K982110 · LPL
Optech, Inc.
Ophthalmic · 143d
Cleared Nov 06, 1998
SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
K982410 · GZJ
Rehabilicare, Inc.
Neurology · 116d
Cleared Nov 06, 1998
IRRIGATION SYRINGE KIT
K982435 · KYZ
Sub-Q, Inc.
General Hospital · 116d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 105d
Cleared Nov 06, 1998
NATURALYTE, MODEL # 08-4004-1
K982813 · KPO
Kaybath, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 06, 1998
ALPHATRAC, MODEL A200
K982815 · ITI
Teftec Corp.
Physical Medicine · 87d
Cleared Nov 06, 1998
BRENNEN MEDICAL BETA GLUCAN GEL
K982825 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 87d
Cleared Nov 06, 1998
MEGA 2000
K982826 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 87d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · IPF
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Nov 06, 1998
FORTE, MODEL CPS ULTRASOUND
K982829 · IMI
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
K982830 · IMG
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Nov 06, 1998
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K982837 · GWG
Karl Storz Endoscopy
Neurology · 86d
Cleared Nov 06, 1998
VINYL EXAMINATION GLOVES, POWDER FREE
K982933 · LYZ
General Gloves Corp.
General Hospital · 78d
Cleared Nov 06, 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · HRX
Xomed, Inc.
Orthopedic · 67d
Cleared Nov 06, 1998
TRITON HUDSON CHUCK ATTACHMENT
K983092 · HBB
Mednext, Inc.
Neurology · 64d
Cleared Nov 06, 1998
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · JDB
Johnson & Johnson Professionals, Inc.
Orthopedic · 59d
Cleared Nov 06, 1998
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
K983218 · FCG
Avid N.I.T., Inc.
Gastroenterology & Urology · 53d
Cleared Nov 06, 1998
VANCOMYCIN EIA ASSAY
K983280 · LEH
Diagnostic Reagents, Inc.
Toxicology · 49d