FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
126361–126384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1990
MODIFIED NON-STERILE LATEX EXAMINATION GLOVES
K902181 · LYY
Aladan Corp.
General Hospital · 30d
Cleared Jun 01, 1990
MODIFIED STERILE LATEX EXAMINATION GLOVES
K902182 · LYY
Aladan Corp.
General Hospital · 30d
Cleared May 31, 1990
GUT SUTURES
K896554 · GAL
Look, Inc.
General & Plastic Surgery · 195d
Cleared May 31, 1990
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)
K897195 · EKS
A Company, Inc.
Dental · 153d
Cleared May 31, 1990
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
K900096 · EWO
Artifical Hearing Systems Corp.
Ear, Nose, Throat · 143d
Cleared May 31, 1990
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
K900178 · EFS
Core-Vent Corp.
Dental · 135d
Cleared May 31, 1990
COOK STEREOTAXIC GUIDE
K900200 · HAW
Cook, Inc.
Neurology · 135d
Cleared May 31, 1990
ENZYMUN TEST(R) DIGOXIN
K901216 · KXT
Boehringer Mannheim Corp.
Toxicology · 78d
Cleared May 31, 1990
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
K901301 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 72d
Cleared May 31, 1990
THE HUESTIS COMPU-PLOTTER
K901567 · IXI
Huestis Machine Corp.
Radiology · 58d
Cleared May 31, 1990
OCULAR INFUSION CANNULA SYSTEM
K901618 · HMX
Tamcenan Corp.
Ophthalmic · 55d
Cleared May 31, 1990
KESTREL LENS CASE (208-12NT POLYSTYRENE)
K901748 · LRX
Kestrel
Ophthalmic · 44d
Cleared May 31, 1990
MODEL 4050-21
K901864 · LNH
Medical Advances, Inc.
Radiology · 36d
Cleared May 31, 1990
NEOCOAT T4
K901939 · CDX
Neometrics, Inc.
Chemistry · 31d
Cleared May 31, 1990
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960 · JMO
American Research Products Co.
Chemistry · 30d
Cleared May 31, 1990
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
K901964 · CEO
American Research Products Co.
Chemistry · 30d
Cleared May 31, 1990
BLOOD GAS/CO-OXIMETRY CONTROL
K901976 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 29d
Cleared May 31, 1990
CO-OXIMETER CONTROLS
K901986 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 29d
Cleared May 31, 1990
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET
K901988 · JJY
Casco Standards
Chemistry · 29d
Cleared May 31, 1990
SFD-035 SPOT FILM DEVICE
K902146 · IXL
Rms Div.
Radiology · 17d
Cleared May 30, 1990
BIOTRACK THEOPHYLLINE TEST CARTRIDGE
K900373 · KLS
Biotrack, Inc.
Toxicology · 124d
Cleared May 30, 1990
HAND CONTROLS, MODEL 3700 AND 3500 SERIES
K900416 · IPQ
Mobility Products & Design
Physical Medicine · 120d
Cleared May 30, 1990
ROTAG CONTROLS
K900719 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 105d
Cleared May 30, 1990
MODEL 2000 INTRAOPERATIVE CORNEASCOPE
K901009 · HLQ
Kera Corp.
Ophthalmic · 86d