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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140689–140712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1987
WHITE PLUME GAUZE SPONGE
K870314 · EFQ
China National Medicines & Health...
General & Plastic Surgery · 27d
Cleared Feb 24, 1987
WHITE PLUME ABSORBENT BANDAGE
K870315
China National Medicines & Health...
General & Plastic Surgery · 27d
Cleared Feb 24, 1987
STERI-TRACTOR WOUND RETRACTOR
K870543 · GAD
3M Company
General & Plastic Surgery · 15d
Cleared Feb 20, 1987
MR338 SERVO HEATED DELIVERY HUMIDIFIER
K863377 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 170d
Cleared Feb 20, 1987
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · GZJ
Cordis Corp.
Neurology · 165d
Cleared Feb 20, 1987
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · BYD
Gambro, Inc.
Anesthesiology · 122d
Cleared Feb 20, 1987
MODIFIED LASERFLO BLOOD PERFUSION MONITOR
K864259 · DPW
Tsi, Inc.
Cardiovascular · 114d
Cleared Feb 20, 1987
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
K864320 · DRQ
Cordis Corp.
Cardiovascular · 109d
Cleared Feb 20, 1987
MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY
K864388 · KKX
Deroyal Industries, Inc.
General Hospital · 106d
Cleared Feb 20, 1987
MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)
K864580 · DPS
Mortara Instrument, Inc.
Cardiovascular · 92d
Cleared Feb 20, 1987
PHONIC EAR MODELS PE 811CS AND PE 811CST
K864672 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Feb 20, 1987
A-TENS - MODEL AI-87
K864735 · GZJ
American Imex
Neurology · 78d
Cleared Feb 20, 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825 · JFJ
Data Medical Associates, Inc.
Chemistry · 73d
Cleared Feb 20, 1987
OLYMPUS PK300
K864834 · JJF
Olympus Corp.
Chemistry · 73d
Cleared Feb 20, 1987
REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.
K864862 · JGS
Hf Scientific, Inc.
Chemistry · 71d
Cleared Feb 20, 1987
API UNISCEPT (TM) KB
K864891 · JWY
Analytical Products, Inc.
Microbiology · 67d
Cleared Feb 20, 1987
MEDICOMP INHALANT MASK ELBOW
K864896 · BZA
Medicomp, Inc.
Anesthesiology · 67d
Cleared Feb 20, 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943 · DQO
NuMED, Inc.
Cardiovascular · 65d
Cleared Feb 20, 1987
ACCUPOINT TOXO
K865068 · LGD
Syva Co.
Microbiology · 53d
Cleared Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · CDT
Sigma Diagnostics, Inc.
Chemistry · 49d
Cleared Feb 20, 1987
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
K870073 · DTL
Clinical Connections, Inc.
Cardiovascular · 43d
Cleared Feb 20, 1987
DIGILAB MODEL 1500 PERIMETER
K870120 · HPT
Bio-Rad
Ophthalmic · 39d
Cleared Feb 20, 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · HKX
Bio-Rad
Ophthalmic · 39d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 38d