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
88681–88704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1998
CARESIDE ANALYZER
K982118 · CHH
Exigent Diagnostics, Inc.
Chemistry · 51d
Cleared Jul 23, 1998
ALTRA FLUX 200 HEMODIALYZER
K970679 · MSF
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 514d
Cleared Jul 23, 1998
ALTRA NOVA 200 HEMODIALYZER
K970681 · MSF
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 514d
Cleared Jul 23, 1998
TSX PRM PULMONARY RESUSCITATION MONITOR
K973347 · CAP
Spiracle Technology
Anesthesiology · 321d
Cleared Jul 23, 1998
ML MICROKERATOME
K981071 · HNO
Med-Logics, Inc.
Ophthalmic · 121d
Cleared Jul 23, 1998
TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
K981078 · CAW
Transtracheal Systems
Anesthesiology · 121d
Cleared Jul 23, 1998
VIPERCAM
K981534 · EIA
Integra Medical
Dental · 85d
Cleared Jul 23, 1998
DENTAL PORCELAIN-VARIOUS
K981708 · FLL
Excel Porcelain Products
General Hospital · 87d
Cleared Jul 23, 1998
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA...
K982269 · MIA
Allegiance Healthcare Corp.
Anesthesiology · 24d
Cleared Jul 22, 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 468d
Cleared Jul 22, 1998
SANDS SERIES III HYPERBARIC CHAMBER
K972908 · CBF
Sands Hyperbarics
Anesthesiology · 350d
Cleared Jul 22, 1998
UBI MAGIWEL MARIJUANA METABOLITES
K973154 · LDJ
United Biotech, Inc.
Toxicology · 334d
Cleared Jul 22, 1998
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456 · BZG
Futuremed America, Inc.
Anesthesiology · 314d
Cleared Jul 22, 1998
DADE INNOVIN
K974343 · GJS
Dade Intl., Inc.
Hematology · 245d
Cleared Jul 22, 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365 · BZD
Nellcor Puritan Bennett, Inc.
Anesthesiology · 174d
Cleared Jul 22, 1998
REFRACTEC MCS-100
K980522 · HQR
Refractec, Inc.
Ophthalmic · 162d
Cleared Jul 22, 1998
VCA IGM ELISA TEST SYSTEM
K980596 · LSE
Clark Laboratories, Inc.
Microbiology · 155d
Cleared Jul 22, 1998
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
K980635 · GKZ
Dako Corp.
Hematology · 153d
Cleared Jul 22, 1998
VCA IGG ELISA TEST SYSTEM
K980912 · LSE
Clark Laboratories, Inc.
Microbiology · 134d
Cleared Jul 22, 1998
SUPERGLOVES POWDERED NITRILE
K980966 · LZA
Supermax Sdn Bhd
General Hospital · 128d
Cleared Jul 22, 1998
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL...
K981083 · DTB
Biotronik, Inc.
Cardiovascular · 120d
Cleared Jul 22, 1998
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY...
K981444 · JHI
Princeton BioMeditech Corp.
Chemistry · 91d
Cleared Jul 22, 1998
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493 · CHH
Polymer Technology Systems, Inc.
Chemistry · 86d
Cleared Jul 22, 1998
TIBC
K981654 · JMO
Abbott Laboratories
Chemistry · 72d