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
129001–129024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1989
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
K894539 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 68d
Cleared Sep 26, 1989
LATEX EXAMINATION GLOVES
K894616 · LYY
World Wide EX Im, Inc.
General Hospital · 68d
Cleared Sep 26, 1989
SURE-TEC LATEX EXAMINATION GLOVES
K894739 · LYY
All American Poly of Pennsylvania Corp.
General Hospital · 61d
Cleared Sep 26, 1989
PATIENT LATEX EXAMINATION GLOVES
K894758 · LYY
Agrimal Industries Sdn. Bhd.
General Hospital · 62d
Cleared Sep 26, 1989
LATEX PATIENT EXAMINATION GLOVE
K894796 · LYY
Bh Limela Industries Sdn. Bhd.
General Hospital · 60d
Cleared Sep 26, 1989
RAPIDEC UR
K894805 · JXA
Dms Products, Inc.
Microbiology · 60d
Cleared Sep 26, 1989
COMFEEL TRANSPARENT DRESSING
K894916 · KGX
Coloplast A/S
General & Plastic Surgery · 55d
Cleared Sep 26, 1989
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942 · DSP
Boston Scientific Corp
Cardiovascular · 54d
Cleared Sep 26, 1989
MEDPRIDE LATEX SURGEONS GLOVES
K895027 · KGO
Medpride
General Hospital · 49d
Cleared Sep 26, 1989
KUT-SHIELD
K895092 · FYH
Kut-Guard, Inc.
General Hospital · 43d
Cleared Sep 26, 1989
MAESTRO PACEMAKER TEST MAGNET
K895110 · DTG
Cardiac Control Systems, Inc.
Cardiovascular · 42d
Cleared Sep 26, 1989
MINIMON 7137B PATIENT MONITOR
K895425 · DQA
Kontron Instruments, Inc.
Anesthesiology · 19d
Cleared Sep 26, 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · DXY
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 26, 1989
LATEX PATIENT EXAMINATION GLOVES
K895536 · LYY
Perfect Latex Pvt. , Ltd.
General Hospital · 13d
Cleared Sep 26, 1989
ORIENT, LATEX EXAMINATION GLOVES
K895558 · LYY
Rosa Intl.
General Hospital · 20d
Cleared Sep 25, 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K885220 · KNT
Ethox Corp.
Gastroenterology & Urology · 279d
Cleared Sep 25, 1989
SERIES 3 GENERAL SUCTION SYSTEM
K891129 · BTA
Ultravac, Inc.
General & Plastic Surgery · 206d
Cleared Sep 25, 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 153d
Cleared Sep 25, 1989
QUICK CHANGE MONTGOMERY STRAP
K893569 · KGX
Med-Dex Intl.
General & Plastic Surgery · 139d
Cleared Sep 25, 1989
NTI-1000
K894097 · QJQ
Neurotek, Inc.
Neurology · 108d
Cleared Sep 25, 1989
FREE T3 RADIOIMMUNOASSAY KIT
K894200 · CDP
Advanced Magnetics, Inc.
Chemistry · 101d
Cleared Sep 25, 1989
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407 · CIC
Abbott Laboratories
Chemistry · 70d
Cleared Sep 25, 1989
FPR DIGOXIN KIT
K894521 · KXT
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR DIGOXIN CALIBRATOR KIT
K894522 · DLJ
Colony Laboratories, Inc.
Toxicology · 67d