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
158641–158664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1982
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
K822806 · DYG
Nova Medical Specialties
Cardiovascular · 45d
Cleared Nov 01, 1982
ACCESS PERCUTANEOUS INTRODUCER SET
K822834 · DYB
Access Devices, Inc.
Cardiovascular · 41d
Cleared Nov 01, 1982
STOOL-COLLECTION/PRESERVATION KIT
K822870 · KDT
American Scientific Products
Microbiology · 35d
Cleared Nov 01, 1982
CORTISOL RIA KIT
K822892 · CGR
Antibodies, Inc.
Chemistry · 34d
Cleared Nov 01, 1982
AUTOECHO
K822903 · DXG
Oxford Medilog, Inc.
Cardiovascular · 34d
Cleared Nov 01, 1982
KALOS-03 BIPOLAR
K822907 · DXY
Biotronik Sales, Inc.
Cardiovascular · 32d
Cleared Nov 01, 1982
PULSE OXIMETER MODEL 100
K822909 · DQA
Nellcor, Inc.
Anesthesiology · 32d
Cleared Nov 01, 1982
MODEL 5400 OPTOKINETIC STIMULATOR
K822917 · HOW
Life-Tech Intl., Inc.
Ophthalmic · 31d
Cleared Nov 01, 1982
CSM CHROMOGENIC B-LACTAMASE DISC
K822930 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 28d
Cleared Nov 01, 1982
THYROID STIMULATING HORMONE
K822935 · JLW
Pcl-Ria, Inc.
Chemistry · 28d
Cleared Nov 01, 1982
560
K822952 · DRT
Kone Instruments, Inc.
Cardiovascular · 28d
Cleared Nov 01, 1982
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · DXH
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 01, 1982
PORTA FIB III
K822961 · LDD
Narco Scientific
Cardiovascular · 27d
Cleared Nov 01, 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972 · DXG
Instrumentation Laboratory CO
Cardiovascular · 24d
Cleared Nov 01, 1982
OPTICATH HEPARIN COATED, FLOW-DIRECT
K823007 · DYG
Oximetrix, Inc.
Cardiovascular · 20d
Cleared Nov 01, 1982
DIGOXIN KIT
K823014 · DPB
Pcl-Ria, Inc.
Toxicology · 19d
Cleared Nov 01, 1982
INTRAVENOUS CATHETER PLACEMENT UNIT &
K823017 · FOZ
Access Devices, Inc.
General Hospital · 19d
Cleared Oct 29, 1982
SOFT LENS THERMAL DISINFECTING UNIT, A-C
K822828 · HRD
Safeway Products, Inc.
Ophthalmic · 38d
Cleared Oct 28, 1982
SIEMENS-ELEMA AB AGA REVIVATOR
K822213 · BTM
Siemens Elema AB
Anesthesiology · 94d
Cleared Oct 28, 1982
RI 300 DIFFERENTIAL TEMPERATURE MONITOR
K822831 · FLL
Instrumentation Industries, Inc.
General Hospital · 37d
Cleared Oct 28, 1982
PLEUR-EVAC A-4005 SYSTEM
K823037 · GCX
Howmedica Corp.
General Hospital · 14d
Cleared Oct 27, 1982
GELRITE
K820610 · JSK
Kelco
Microbiology · 233d
Cleared Oct 27, 1982
TYMPANOSTOMY TUBES & VARIOUS TYPES
K822017 · ETD
Kelleher Corp.
Ear, Nose, Throat · 111d
Cleared Oct 27, 1982
TPK 1980/1
K822449 · LCX
Plantex USA, Inc.
Chemistry · 72d