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
87025–87048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1999
SHEER GLYDE DAMS
K990067 · MSC
Louise C. Myers
Obstetrics & Gynecology · 42d
Cleared Feb 19, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED
K990081 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 39d
Cleared Feb 19, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K990117 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 37d
Cleared Feb 19, 1999
GUTHRIE PRIME POWDER-FREE
K990228 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 25d
Cleared Feb 18, 1999
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · HAX
Friddle'S Orthopedic Appliances, Inc.
Neurology · 360d
Cleared Feb 18, 1999
BAHO AUTOCLAVABLE LAPAROSCOPE
K982276 · HET
Microptix Int'L, LLC
Obstetrics & Gynecology · 234d
Cleared Feb 18, 1999
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
K983160 · LPL
Hydron , Ltd.
Ophthalmic · 162d
Cleared Feb 18, 1999
BLASTOCYST MEDIUM
K983580 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 18, 1999
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS),...
K983586 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 18, 1999
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM
K983589 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 18, 1999
SYSTEM U3
K983890 · JWY
Ab Biodisk
Microbiology · 108d
Cleared Feb 18, 1999
PRONOSCO X-POSURE SYSTEM
K984178 · KGI
Torsana Osteoporosis Diagnostics A/S
Radiology · 90d
Cleared Feb 18, 1999
CROSSTEX NON-WOVEN SPONGES
K984187 · EFQ
Crosstex Intl.
General & Plastic Surgery · 87d
Cleared Feb 18, 1999
WIDE BODY ABUTMENTS
K984198 · DZE
Vident
Dental · 86d
Cleared Feb 18, 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Feb 18, 1999
MEDART 455 SCANNER SYSTEM
K984339 · GEX
Del Mar Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Feb 18, 1999
A-SOFT RELINER
K984483 · EBI
S & C Polymer GmbH
Dental · 64d
Cleared Feb 18, 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498 · KTT
Synthes (Usa)
Orthopedic · 63d
Cleared Feb 18, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED...
K984544 · LYR
Enteric Products, Inc.
Microbiology · 58d
Cleared Feb 18, 1999
MODULAR PROTUSIO CUP
K990032 · JDI
Biomet, Inc.
Orthopedic · 43d
Cleared Feb 18, 1999
KMI WRIST FUSION SYSTEM
K990094 · HRS
Kinetikos Medical, Inc.
Orthopedic · 37d
Cleared Feb 18, 1999
ANATOMICA HUMERAL STEM/HEAD COMPONENTS
K990137 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 35d
Cleared Feb 18, 1999
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
K990203 · MEH
Osteonics Corp.
Orthopedic · 28d
Cleared Feb 18, 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 21d