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
130753–130776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1989
VERSION 4.2 APPLICATION SOFTWARE
K892959 · LNH
Resonex, Inc.
Radiology · 38d
Cleared Jun 01, 1989
AOR-SULLIVAN PROTECTIVE OVERGLOVE
K893118 · LYU
Aor-Sullivan
General Hospital · 37d
Cleared Jun 01, 1989
ROBOTRAC (TM) RETRACTOR ARM
K893121 · GAD
Aesculap Instruments Corp.
General & Plastic Surgery · 37d
Cleared Jun 01, 1989
CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB
K893129 · IZZ
Continental X-Ray Corp.
Radiology · 37d
Cleared Jun 01, 1989
MUC-X
K893204 · BSY
Island Medical
Anesthesiology · 36d
Cleared Jun 01, 1989
THERMALAP
K893212 · KKX
O.R. Concepts, Inc.
General Hospital · 35d
Cleared May 31, 1989
HORIZON DISPLAY CONTROLLER PART # 266-200-010
K884423 · DXJ
Mennen Medical, Inc.
Cardiovascular · 224d
Cleared May 31, 1989
MEDILOG EXCEL ECG ANALYSIS SYSTEM
K885256 · DSI
Oxford Medical, Inc.
Cardiovascular · 159d
Cleared May 31, 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
K890207 · DQX
E-Z-Em, Inc.
Cardiovascular · 134d
Cleared May 31, 1989
ESOPHAGEAL OVERTUBE
K890629 · FED
Gastrotech, Inc.
Gastroenterology & Urology · 110d
Cleared May 31, 1989
MEDTRONIC MODEL 5866-45 SIZING SLEEVE
K890644 · DTB
Medtronic Vascular
Cardiovascular · 112d
Cleared May 31, 1989
LATEX EXAMINATION GLOVE
K890651 · LYY
Tianjin Tang GU Latex Factory
General Hospital · 112d
Cleared May 31, 1989
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
K891008 · LXV
Micromedical Technologies, Inc.
Ear, Nose, Throat · 89d
Cleared May 31, 1989
OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1
K891225 · IYO
Canon USA, Inc.
Radiology · 85d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891342 · LYY
Tiger Marketing, Inc.
General Hospital · 82d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891436 · LYY
Amerimed US Corp.
General Hospital · 77d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891437 · LYY
Amerimed US Corp.
General Hospital · 77d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891438 · LYY
Interpro Intl., Inc.
General Hospital · 77d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891440 · LYY
Interpro Intl., Inc.
General Hospital · 77d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891620 · LYY
Albors-Menconi Latex Corp.
General Hospital · 75d
Cleared May 31, 1989
SAMBORO LATEX PATIENT EXAMINATION GLOVES
K891643 · LYY
Ktp Gloves Industrial Corp.
General Hospital · 75d
Cleared May 31, 1989
LIB SYSTEM, BABY/ADULT DIAPER
K891686 · EYQ
Intera Corp.
Gastroenterology & Urology · 70d
Cleared May 31, 1989
EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
K891687 · DTZ
Medtronic Blood Systems, Inc.
Cardiovascular · 70d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891821 · LYY
Koon Seng Sdn Bhd
General Hospital · 68d