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
144217–144240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1986
IONIZED CALCIUM AND BLOOD PH TESTCARDS
K860639 · JFP
Ilex Corp.
Chemistry · 60d
Cleared Apr 21, 1986
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726 · LFR
Trace Scientific , Ltd.
Chemistry · 54d
Cleared Apr 21, 1986
AM-100 I/A AMPAC
K860770 · HQC
Dravon Medical, Inc.
Ophthalmic · 49d
Cleared Apr 21, 1986
WRAPPERS, SUNGLASSES
K860794 · HQG
Mhci Corp.
Ophthalmic · 48d
Cleared Apr 21, 1986
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
K860891 · HQE
Intra-Optics Labs. C/O Newman Assoc.
Ophthalmic · 42d
Cleared Apr 21, 1986
VISION SGPT (ALT)
K861002 · CKA
Abbott Laboratories
Chemistry · 34d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 21, 1986
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
K861301 · JTZ
Troy Biologicals, Inc.
Microbiology · 14d
Cleared Apr 18, 1986
AMBULASE
K852436 · GEX
Xanar, Inc.
General & Plastic Surgery · 312d
Cleared Apr 18, 1986
GREENLEAF SMART POLYGRAPH PROGRAM
K854355 · BZQ
Greenleaf Science Corp.
Anesthesiology · 171d
Cleared Apr 18, 1986
REUMAGEN ASL
K854991 · GTQ
Biokit USA, Inc.
Microbiology · 127d
Cleared Apr 18, 1986
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K860162 · FRN
Travenol Laboratories, S.A.
General Hospital · 91d
Cleared Apr 18, 1986
SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
K860354 · JCF
Sepratech Corporation C/O Keller and...
Hematology · 78d
Cleared Apr 18, 1986
EBI HAND MASSAGING PUMP (HMP)
K860632 · IRP
Electro-Biology, Inc.
Physical Medicine · 57d
Cleared Apr 18, 1986
BIODEX SYSTEM
K860821 · IKK
Biodex Corp.
Physical Medicine · 45d
Cleared Apr 18, 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · KTN
Gamma Biologicals, Inc.
Immunology · 31d
Cleared Apr 18, 1986
NAUTILUS LEG EXTENSION TESTING & REHABILITATION
K861206 · IKK
Nautilus Sports/Medical Industries, Inc.
Physical Medicine · 18d
Cleared Apr 18, 1986
AQUA ARK, IMMERSION HYDROBATH
K861218 · ILJ
Aqua Ark, Inc.
Physical Medicine · 18d
Cleared Apr 18, 1986
BASIC LIGHT
K861289 · KZF
Burton Medical Products Corp.
General Hospital · 11d
Cleared Apr 18, 1986
LYFO-KWIK (TM) COAGULASE PLASMA
K861312 · JTL
Micro-Bio-Logics
Hematology · 10d
Cleared Apr 18, 1986
HUMAN LUNG CARCINOMA CELLS (A549)
K861373 · KIR
Viromed Laboratories, Inc.
Pathology · 7d
Cleared Apr 18, 1986
SOLEX THERAPEUTIC PAD
K861383 · IRT
Intl. Diathermics Research, Inc.
Physical Medicine · 4d
Cleared Apr 17, 1986
6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
K844772 · ITX
Philips Medical Systems, Inc.
Radiology · 498d