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
154417–154440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1984
COAXIAL VOL. VENTILATOR CIRCUIT
K833459 · BZO
Airco/Ohio Medical Products
Anesthesiology · 97d
Cleared Jan 10, 1984
DIATEK 600 THERMOMETER SYSTEM
K833568 · FLL
Diatek, Inc.
General Hospital · 90d
Cleared Jan 10, 1984
COULTER COUNTER MODEL S-PLUS V
K833600 · GKZ
Coulter Electronics, Inc.
Hematology · 90d
Cleared Jan 10, 1984
DENTAL RUBBERDAM
K833610 · EIE
Center For Marketing Services
Dental · 89d
Cleared Jan 10, 1984
STERILE OIL AND GUIDEWIRE
K833671 · HNL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jan 10, 1984
LP200 & HP800 SERIES VASCULAR PROSTH
K833716 · DSY
Intervascular, Inc.
Cardiovascular · 81d
Cleared Jan 10, 1984
STERILIZATION OF GORE-TEX SOFT TISSU
K833764 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 76d
Cleared Jan 10, 1984
MULTI-LUMEN INTRAVENOUS INFUSION CATH
K833825 · DQY
Medical Parameters, Inc.
Cardiovascular · 69d
Cleared Jan 10, 1984
HEPARIN COATED BALLOON THERMODILU
K834036 · DYG
Nova Medical Specialties
Cardiovascular · 48d
Cleared Jan 10, 1984
HEPARIN COATED BALLOON THERMODILU
K834037 · DYG
Nova Medical Specialties
Cardiovascular · 48d
Cleared Jan 10, 1984
SLO-FLO 40AL ADJUST-FLOW REGULATOR
K834061 · CAN
S.L.O. Health Products, Inc.
Anesthesiology · 46d
Cleared Jan 10, 1984
MEDELA APGAR TIMER
K834129 · LHB
Medela, Inc.
General Hospital · 41d
Cleared Jan 10, 1984
BONE PLUGGING TOOL
K834229 · HTW
Standard Surgical
Orthopedic · 35d
Cleared Jan 10, 1984
RECON-2 FLOW CONTROLLER
K834260 · CAX
Precision Metering, Inc.
Anesthesiology · 34d
Cleared Jan 10, 1984
DIGITAL RADIOGRAPHY SYS-DPS7100
K834287 · JAA
Adac Laboratories
Radiology · 46d
Cleared Jan 10, 1984
MULTITREAT 48
K834308 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 67d
Cleared Jan 10, 1984
APO A-I RIA KIT-HUMAN PLASMA APOLIP-
K840105
Iso-Tex Diagnostics
Chemistry
Cleared Jan 09, 1984
MEDICALEX
K831728 · FQM
Medicalex
General Hospital · 223d
Cleared Jan 09, 1984
PREGNASTICK URINE HCG KIT
K833504 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 96d
Cleared Jan 09, 1984
MARZ-175 ARTERIAL BLOOD GAS SYRINGE
K833923 · CBT
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 56d
Cleared Jan 09, 1984
NYLON COMPRESSION STUMP SHEATH
K834143
Ipos Luneburg
Physical Medicine · 39d
Cleared Jan 06, 1984
GORE-TEX SURGICAL MEMBRANE
K831516 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 302d
Cleared Jan 06, 1984
IRRIGATION ASPIRATION KIT
K833405 · HQC
American Medical Optics
Ophthalmic · 98d
Cleared Jan 04, 1984
M.S.D. ASPIRATOR
K832529 · HQC
Medical Surgical Designs
Ophthalmic · 159d