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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112969–112992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
K932076 · JJY
Bio-Rad
Chemistry · 61d
Cleared Jun 29, 1993
CANNABINOID URINE CONTROLS
K932113 · JJX
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Jun 29, 1993
SAS(TM) SERUM/URINE HCG
K932409 · DHA
Sa Scientific, Inc.
Chemistry · 42d
Cleared Jun 29, 1993
DOCUMENT ENZYME
K932458 · JJY
Casco Standards
Chemistry · 39d
Cleared Jun 28, 1993
TURBIQUANT ASL
K915742 · GTQ
Behring Diagnostics, Inc.
Microbiology · 553d
Cleared Jun 28, 1993
I.V. START KIT, STERILE, DISPOSABLE
K923361 · LRS
Trinity Laboratories, Inc.
General & Plastic Surgery · 355d
Cleared Jun 28, 1993
MULTITROL IMMUNOLOGY CONTROL
K923663 · JJY
Behring Diagnostics, Inc.
Immunology · 341d
Cleared Jun 28, 1993
OP3/VP4
K924516 · HGL
Huntleigh Technology, Inc.
Radiology · 297d
Cleared Jun 28, 1993
BERICHROM HEPARIN
K925200 · KFF
Behring Diagnostics, Inc.
Hematology · 255d
Cleared Jun 28, 1993
NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL)
K925736 · HQY
Eyeworks 3
Ophthalmic · 227d
Cleared Jun 28, 1993
OPTI-FREE CONTACT LENS CASE
K931620 · LRX
Alcon Laboratories
Ophthalmic · 87d
Cleared Jun 25, 1993
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
K915841 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 549d
Cleared Jun 25, 1993
ARGIS PULMONARY FUNCTION TESTING SYSTEM
K921306 · BZC
Med Science
Anesthesiology · 464d
Cleared Jun 25, 1993
PENTAX XENON LIGHT SOURCE
K921315 · GCT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 464d
Cleared Jun 25, 1993
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
K922646 · JIS
Behring Diagnostics, Inc.
Chemistry · 387d
Cleared Jun 25, 1993
LAPAROSCOPIC NEEDLE HOLDER
K924196 · FHQ
Nusurg, Inc.
Gastroenterology & Urology · 309d
Cleared Jun 25, 1993
LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION
K924410 · GEI
Core Dynamics, Inc.
General & Plastic Surgery · 298d
Cleared Jun 25, 1993
ENDOPATH ENDOSCOPIC TISSUE RETRACTOR
K924916 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 269d
Cleared Jun 25, 1993
ORC 10.0MM SUCTION PROBE
K925147 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 255d
Cleared Jun 25, 1993
BIONOR TRANSPORTMEDIUM
K925450 · JSL
Skoug Research Corp.
Microbiology · 240d
Cleared Jun 25, 1993
BALT INTRODUCER
K925633 · DYB
Target Therapeutics
Cardiovascular · 228d
Cleared Jun 25, 1993
POWDER FREE LATEX EXAM GLOVES
K925685 · LYY
M.M. Rubber Co. , Ltd.
General Hospital · 225d
Cleared Jun 25, 1993
ECLIPSE 3200
K925840 · GEX
Cardiogenes
General & Plastic Surgery · 227d
Cleared Jun 25, 1993
SURGICAL DISSECTOR WITH CANNULA
K926010 · GCJ
General Surgical Innovations
General & Plastic Surgery · 210d