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
88417–88440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1998
AUTOCORR PLUS
K981939 · DQA
Bci Intl., Inc.
Anesthesiology · 79d
Cleared Aug 20, 1998
ULTIMA BODY POSITION SENSOR
K981969 · LEL
Braebon Medical Corp.
Neurology · 77d
Cleared Aug 20, 1998
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112 · LHQ
Thermatrek, Inc.
Radiology · 65d
Cleared Aug 20, 1998
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · KGN
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 27d
Cleared Aug 20, 1998
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100,...
K982626 · EZL
Medworks Corp.
Gastroenterology & Urology · 23d
Cleared Aug 20, 1998
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
K982755 · CAC
Medtronic Blood Management
Anesthesiology · 52d
Cleared Aug 19, 1998
FUTREX-6100/XL
K963271 · MNW
Futrex, Inc.
Gastroenterology & Urology · 729d
Cleared Aug 19, 1998
SIEMENS SEVOFLURANE VAPORIZER SV 953
K980884 · CAD
Siemens Medical Solutions USA, Inc.
Anesthesiology · 163d
Cleared Aug 19, 1998
KSEA ENDO TIP SYSTEM
K981130 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 142d
Cleared Aug 19, 1998
CARDIOVISION SOFTWARE, MODEL S-CV5-96
K981807 · DPS
Shl Telemedicine International , Ltd.
Cardiovascular · 90d
Cleared Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289 · KNS
Olympus America, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 19, 1998
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
K982383 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 42d
Cleared Aug 19, 1998
HICHEM CHOLESTEROL REAGENT KIT
K982469 · CHH
Elan Pharma, Inc.
Chemistry · 35d
Cleared Aug 19, 1998
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608 · CKG
Sangui Biotech, Inc.
Chemistry · 23d
Cleared Aug 18, 1998
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
K980109 · KYX
Sangstat Medical Corp.
General Hospital · 218d
Cleared Aug 18, 1998
CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
K980588 · GAD
Clarus Medical Systems, Inc.
General & Plastic Surgery · 182d
Cleared Aug 18, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 160d
Cleared Aug 18, 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 18, 1998
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K981846 · GWM
Camino Neurocare, Inc.
Neurology · 84d
Cleared Aug 18, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
K981854 · JIT
Olympus Diagnostica GmbH
Chemistry · 84d
Cleared Aug 18, 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · JEY
Synthes (Usa)
Dental · 81d
Cleared Aug 18, 1998
QUICK & SURE ONESTEP HOME PREGNANCY TEST
K981892 · LCX
Abacus Diagnostics
Chemistry · 81d
Cleared Aug 18, 1998
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO....
K981905 · FOZ
Acu-Pak
General Hospital · 78d
Cleared Aug 18, 1998
APOLLO 95E
K981948 · EBF
Dental/Medical Diagnostic Systems, Inc.
Dental · 76d