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
139057–139080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1987
MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S
K871434 · LRO
Fraass Survival Systems, Inc.
General & Plastic Surgery · 87d
Cleared Jul 09, 1987
SURVIVAL KIT, INDIVIDUAL
K871437 · LRO
Fraass Survival Systems, Inc.
General & Plastic Surgery · 87d
Cleared Jul 09, 1987
SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
K871458 · KDD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 87d
Cleared Jul 09, 1987
SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI
K871513 · LNK
Medical Energy, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 09, 1987
SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID
K871514 · LNK
Medical Energy, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 09, 1987
SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING
K871515 · LNK
Medical Energy, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 09, 1987
SL-100 ND:YAG LASER FOR UROLOGIC SURGERY
K871516 · LNK
Medical Energy, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 09, 1987
MODIFIED LABELING FOR AMUKIN-50%
K871583 · KDJ
Amuchina Intl., Inc.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1987
CLOSED CHEST DRAINAGE SET
K871873 · LRO
Gish Biomedical, Inc.
General & Plastic Surgery · 57d
Cleared Jul 09, 1987
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
K871977 · JJY
American Dade
Chemistry · 48d
Cleared Jul 09, 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · DFT
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 29d
Cleared Jul 09, 1987
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · JGJ
Abbott Laboratories
Chemistry · 22d
Cleared Jul 09, 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330 · DKJ
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jul 09, 1987
CHROM-TROL
K872377 · JPA
Helena Laboratories
Hematology · 20d
Cleared Jul 09, 1987
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K872465 · KIT
J R Scientific
Microbiology · 16d
Cleared Jul 09, 1987
HITACHI 717 CHEMISTRY ANALYZER
K872494 · JJE
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jul 09, 1987
HARRIS HEMATOXYLIN
K872498 · HYK
Anatech, Ltd.
Pathology · 15d
Cleared Jul 09, 1987
ANATECH HEMATOXYLIN-NORMAL STRENGTH
K872499 · HYJ
Anatech, Ltd.
Pathology · 15d
Cleared Jul 09, 1987
ANATECH HEMATOXYLIN-EXTRA STRENGTH
K872500 · HYJ
Anatech, Ltd.
Pathology · 15d
Cleared Jul 09, 1987
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K872507 · JSM
Precision Dynamics Corp.
Microbiology · 15d
Cleared Jul 08, 1987
ACID FUCHSIN SOLUTIONS
K870889 · FKQ
D.R.G. Scientific Industries
Gastroenterology & Urology · 125d
Cleared Jul 08, 1987
ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER
K871424 · LMS
Hgm, Inc.
Ear, Nose, Throat · 90d
Cleared Jul 08, 1987
PALEX (R) OSTOMY
K871628 · EXB
Industrias Palex C/O Dma Med-Chem Corp.
Gastroenterology & Urology · 72d
Cleared Jul 08, 1987
TOTAL LUNG EXERCISER (TLE)
K871904 · BWF
MBA Healthcare Products, Inc.
Anesthesiology · 54d