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
125785–125808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 30, 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · LIT
Boston Scientific Corp
Cardiovascular · 86d
Cleared May 30, 1990
COULTER ALBUMIN REAGENT
K901268 · CIX
Coulter Corp.
Chemistry · 75d
Cleared May 30, 1990
TABA PATIENT EXAMINATION GLOVES
K901749 · LYY
R.S.T. Corp.
General Hospital · 43d
Cleared May 30, 1990
SIEMENS SIRECUST 732, PATIENT MONITOR
K901771 · DPS
Siemens Medical Electronics
Cardiovascular · 41d
Cleared May 30, 1990
PARA 12 PLUS
K901875 · JCN
Streck Laboratories, Inc.
Hematology · 34d
Cleared May 29, 1990
LIFT MASTER PATIENT LIFT
K896848 · FNG
Henry Enterprises, Inc.
General Hospital · 175d
Cleared May 29, 1990
ULTRA-TRAC
K900575 · ITH
Practical Healthcare Devices, Inc.
Physical Medicine · 111d
Cleared May 29, 1990
COPAL VARNISH
K901049 · LBH
Pulpdent Corp.
Dental · 85d
Cleared May 29, 1990
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077 · EBG
Scientific Pharmaceuticals, Inc.
Dental · 83d
Cleared May 29, 1990
SPARTAN PLUS
K901098 · EJT
Ivoclar North America, Inc.
Dental · 83d
Cleared May 29, 1990
CHALLENGE 20 POWERED MUSCLE STIMULATOR
K901326 · IPF
Maximum Performance Technologies,...
Physical Medicine · 69d
Cleared May 29, 1990
MAYFLOWER BRAND PATIENT EXAMINATION GLOVES
K901376 · LYY
Kai FU Trading Co.
General Hospital · 68d
Cleared May 29, 1990
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
K901617 · HRX
Smith & Nephew, Inc.
Orthopedic · 53d
Cleared May 29, 1990
RESUBMITTED ISG 3DMV WORKSTATION
K901679 · LLZ
I.S.G. Technologies, Inc.
Radiology · 47d