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
86905–86928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1999
DENTAL STERLIZATION TRAY/CASSETTE
K983223 · FRG
Brasseler USA I, L.P.
General Hospital · 122d
Cleared Jan 14, 1999
GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
K983570 · LYY
Glove Seal Sdn Bhd
General Hospital · 93d
Cleared Jan 14, 1999
STEALTHSTATION SYSTEM
K983670 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 87d
Cleared Jan 14, 1999
UNIK TONGUE CLEANER
K983683 · LCN
Unik Products, Inc.
Dental · 86d
Cleared Jan 14, 1999
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
K983814 · JDO
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 78d
Cleared Jan 14, 1999
PACSCACHE
K983815 · LLZ
Dome Imaging Systems, Inc.
Radiology · 78d
Cleared Jan 14, 1999
MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
K983827 · LYY
Sinetimed Latex Sdn Bhd
General Hospital · 76d
Cleared Jan 14, 1999
HYS-SURGIFLATOR 150P
K983889 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 73d
Cleared Jan 14, 1999
VINYL EXAMINATION GLOVES, PREPOWDERED USP
K984094 · LYZ
Trans Ancient Products Co., Ltd.
General Hospital · 59d
Cleared Jan 14, 1999
MODIFICATION OF PURESPERM
K984172 · MQL
Nidacon International AB
Obstetrics & Gynecology · 55d
Cleared Jan 14, 1999
AZTECH 70
K984524 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Jan 14, 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · KWT
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jan 14, 1999
TALKING DIGITAL THERMOMETER, MODEL KV-171
K984553 · FLL
K-Jump Health Co., Ltd.
General Hospital · 23d
Cleared Jan 14, 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K984575 · LPN
Alcon Laboratories
Ophthalmic · 22d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15...
K981173 · GJT
Precision Biologicals, Inc.
Hematology · 287d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15...
K981174 · GJT
Precision Biologicals, Inc.
Hematology · 287d
Cleared Jan 13, 1999
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
K982062 · GGW
Precision Biologicals, Inc.
Hematology · 212d
Cleared Jan 13, 1999
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
K982115 · LYL
Rim-Wide Companies, Inc.
Ophthalmic · 211d
Cleared Jan 13, 1999
HEART-LIFT BALLOON POSITIONER
K982419 · MWS
Cardiothoracic Systems, Inc.
Cardiovascular · 184d
Cleared Jan 13, 1999
SERAQUEST CMV IGM
K982485 · LFZ
Quest Intl., Inc.
Microbiology · 180d
Cleared Jan 13, 1999
SNN SCOUT
K982570 · HAW
I.S.G. Technologies, Inc.
Neurology · 174d
Cleared Jan 13, 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · KGO
Terang Nusa Sdn Bhd
General Hospital · 142d
Cleared Jan 13, 1999
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
K983544 · LJS
Vygon Corp.
General Hospital · 96d
Cleared Jan 13, 1999
MB/BACT BLOOD CULTURE BOTTLE
K983772 · MDB
Organon Teknika Corp.
Microbiology · 79d