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
156577–156600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311 · FPA
Travenol Laboratories, S.A.
General Hospital · 47d
Cleared Jun 08, 1983
COMPUR* M1100 HEMATRCRIT SYSTEM
K831318 · JPI
Worthington Diagnostic Systems
Hematology · 47d
Cleared Jun 08, 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339 · JHJ
Organon, Inc.
Immunology · 44d
Cleared Jun 08, 1983
DRAIN-R-DRAPE(EYE
K831340 · HMT
Sur-Tech, Inc.
General Hospital · 44d
Cleared Jun 08, 1983
RIANEN PROLACTIN 125I KIT
K831345 · CFT
New England Nuclear
Chemistry · 44d
Cleared Jun 08, 1983
ASTRA SYSTEMS ENZYME MODULE
K831353 · CFJ
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jun 08, 1983
DATA-ZYME ALKALINE PHOSPHATASE PROCED
K831360 · CJE
Data Medical Associates, Inc.
Microbiology · 43d
Cleared Jun 08, 1983
SOMATRON
K831394 · JFB
Somatron Co.
Physical Medicine · 40d
Cleared Jun 08, 1983
LINEAR ENZMATIC URIC ACID SYSTEM
K831398 · KNK
Simmler, Inc.
Chemistry · 40d
Cleared Jun 08, 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 37d
Cleared Jun 08, 1983
SPEC IISX
K831413 · GZJ
Medical Devices, Inc.
Neurology · 37d
Cleared Jun 08, 1983
EMIT QST TOBRAMYCIN ASSAY
K831416 · LCD
Syva Co.
Toxicology · 36d
Cleared Jun 08, 1983
ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS
K831426
New England Surgical Instrument Corp.
Orthopedic · 36d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442 · DHB
Pharmacia, Inc.
Chemistry · 34d
Cleared Jun 08, 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448 · LIB
R&D Systems, Inc.
Chemistry · 34d
Cleared Jun 08, 1983
SILCATH CENTRAL CATHETER TRAY SIZE-
K831451 · JCY
Argon Medical Corp.
General & Plastic Surgery · 34d
Cleared Jun 08, 1983
ANA-CHECK
K831463 · LKJ
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
CRP-CHECK
K831465 · DCN
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
RA-CHECK
K831467 · DHR
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
LEGIONELLA CYE AGAR BASE & BCYE SUPPL
K831469 · JSK
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Jun 08, 1983
DAVRON PROF. SCRUB BRUSH-DRY/STERILE
K831488 · GEC
Minnetonka, Inc.
General & Plastic Surgery · 29d
Cleared Jun 08, 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · DQO
Mallinckrodt Critical Care
Cardiovascular · 28d