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
110977–111000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1993
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623 · JIX
Quantimetrix Corp.
Chemistry · 191d
Cleared Dec 09, 1993
TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
K932846 · GDY
Courtaulds Fibers, Inc.
General & Plastic Surgery · 182d
Cleared Dec 09, 1993
SIGMA CO2 ACID REAGENT
K933692 · JFL
Sigma Chemical Co.
Chemistry · 133d
Cleared Dec 09, 1993
PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER
K933896 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 121d
Cleared Dec 09, 1993
PHX TECHNOLOGIES CORP., 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA CLEANER
K933897 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 121d
Cleared Dec 09, 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · LIT
Boston Scientific Corp
Cardiovascular · 105d
Cleared Dec 09, 1993
LOC GUIDE WIRE EXTENSION
K934339 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 93d
Cleared Dec 09, 1993
VANTAGE DIALTAION CATHETER
K934433 · LIT
Peripheral Systems Group
Cardiovascular · 87d
Cleared Dec 09, 1993
I-STAT CONTROL LEVELS 1,2,3
K934641 · JJR
I-Stat Corp.
Chemistry · 79d
Cleared Dec 09, 1993
SPINPRO HDL PRECIPITATING REAGENT
K934961 · LBR
Merchant House Scientific
Chemistry · 55d
Cleared Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Dec 09, 1993
EMDS MAGNESIUM (MG) TEST
K935183 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Dec 08, 1993
SUNGLASSES
K925539 · HQY
Sunshine Opticians, Inc.
Ophthalmic · 401d
Cleared Dec 08, 1993
SPECTACLE FRAME
K930331 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 320d
Cleared Dec 08, 1993
MITEK SUPER QUICKANCHOR, MODIFICATION
K930893 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 313d
Cleared Dec 08, 1993
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · DTB
Medtronic Vascular
Cardiovascular · 217d
Cleared Dec 08, 1993
SCIMED MAVERICK PTA CATHETER
K932537 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 196d
Cleared Dec 08, 1993
SECURODRIP (TM) I.V. ARMBOARD
K932757 · KMK
Op-Co Medical Products , Ltd.
General Hospital · 187d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392 · MID
Elias U.S.A., Inc.
Immunology · 149d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393 · MID
Elias U.S.A., Inc.
Immunology · 149d
Cleared Dec 08, 1993
PHOTOSTRESS RECOVERY TESTER
K933814 · GXY
Storz Instrument Co.
Neurology · 126d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 114d
Cleared Dec 08, 1993
ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
K934248 · EBI
Wallace A. Erickson & Co.
Dental · 100d
Cleared Dec 08, 1993
SPECTACLE FRAMES
K934301 · HQZ
Gernot Lindner, Lunor-Vertrieb
Ophthalmic · 97d