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
127081–127104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1990
SHOWER CHAIRS
K895740 · FPO
Lumex, Inc.
General Hospital · 149d
Cleared Feb 22, 1990
MODEL 219 TELEMETRY SYSTEM
K895895 · GYE
Mennen Medical, Inc.
Neurology · 139d
Cleared Feb 22, 1990
LOPER CELIAC PLEXUS BLOCK CATHETER KIT
K895955 · CAZ
Opticon Medical, Inc.
Anesthesiology · 134d
Cleared Feb 22, 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
K895971 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 132d
Cleared Feb 22, 1990
KELLER PULSE OXIMETER - KMS 850
K895987 · DQA
Keller Medical Specialties Products,...
Anesthesiology · 133d
Cleared Feb 22, 1990
S-ROM(TM)/NOILES(TM) MARK 5 KNEE
K896397 · JWH
Joint Medical Products Corp.
Orthopedic · 107d
Cleared Feb 22, 1990
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · EMA
Confi-Dental Products Co.
Dental · 90d
Cleared Feb 22, 1990
LORENZ STENT
K896667 · FWN
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Feb 22, 1990
BICORE VARIFLEX(R) FLOW TRANSDUCER
K896718 · BYR
Bicore Monitoring Systems
Anesthesiology · 85d
Cleared Feb 22, 1990
PRIMER-P ADHESIVE AGENT
K896719 · EBI
Parkell
Dental · 85d
Cleared Feb 22, 1990
TRACHEOSTOMY TRAY
K896798 · BTO
Westmark, Sterile Packing Systems,...
Anesthesiology · 83d
Cleared Feb 22, 1990
HALUX EXLITE MINOR SURGERY LIGHT
K896961 · GBC
Jedmed Instrument Co.
General & Plastic Surgery · 69d
Cleared Feb 22, 1990
CRAGG CONVERTIBLE WIRE
K897152 · DQX
Boston Scientific Corp
Cardiovascular · 58d
Cleared Feb 22, 1990
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
K897157 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 58d
Cleared Feb 22, 1990
BIOPOTENTIAL SURFACE ELECTRODE
K900059 · GXY
Integral Design, Inc.
Neurology · 50d
Cleared Feb 22, 1990
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
K900115 · CAN
Ventlab Corp.
Anesthesiology · 44d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
K900237 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
K900238 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 22, 1990
ACU-BAND ACCUPRESSURE WRIST BAND
K900588 · MVV
Euro-Am Pharma, Inc.
Neurology · 15d
Cleared Feb 22, 1990
BOOSTER MOTORIZED THREE WHEELED VEHICLE
K900738 · INI
Burke Mobility Products
Physical Medicine · 6d
Cleared Feb 21, 1990
HYDRASORB(TM)
K897156 · NAD
Avitar, Inc.
General & Plastic Surgery · 57d
Cleared Feb 21, 1990
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
K900108 · DGC
3M Company
Immunology · 43d
Cleared Feb 21, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
K900244 · DGC
3M Company
Immunology · 35d
Cleared Feb 21, 1990
WOODLYN SLIT LAMP MODEL HR-1
K900476 · HJO
Woodlyn, Inc.
Ophthalmic · 20d