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
86521–86544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 18, 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
K990285 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 20d
Cleared Feb 18, 1999
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
K990339 · IYN
Hewlett-Packard Co.
Radiology · 15d
Cleared Feb 17, 1999
GLIADIN ANTIBODIES ELISA
K973910 · MST
Genesis Diagnostics , Ltd.
Immunology · 491d
Cleared Feb 17, 1999
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
K982721 · JEY
Bionx Implants, Inc.
Dental · 197d
Cleared Feb 17, 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · JPK
R&D Systems, Inc.
Hematology · 170d
Cleared Feb 17, 1999
CARE BAND ANTIBACTERIAL BANDAGES
K983368 · KGX
Aso Corp.
General & Plastic Surgery · 146d
Cleared Feb 17, 1999
BIPORE BALLOON DILATATION CATHETER
K983650 · LIT
Bipore, Inc.
Cardiovascular · 124d
Cleared Feb 17, 1999
EXONIX
K984199 · IMI
Fibra Sonics, Inc.
Physical Medicine · 85d
Cleared Feb 17, 1999
POWDERED NITRILE EXAMINATION GLOVES
K984615 · LZA
Shiva Medicare , Ltd.
General Hospital · 50d