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
132217–132240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1989
OXYGENATION CATHETER
K881881 · BTM
Ventech Healthcare Corp., Inc.
Anesthesiology · 289d
Cleared Feb 17, 1989
NITRONOX(R), FIRST RESPONSE NITRONOX(TM)
K883833 · BZR
Matrix Medica, Inc.
Anesthesiology · 161d
Cleared Feb 17, 1989
AXIOM ATRAUM WOUND DRAINS
K883887 · GBS
Axiom, Inc.
General & Plastic Surgery · 157d
Cleared Feb 17, 1989
DRUG STANDARD SET
K884177 · DKB
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 17, 1989
DRUG CONTROL SET
K884178 · DIF
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 17, 1989
STAAR PHACO XL SMALL INCISION SYSTEM
K884241 · HQC
Staar Surgical Co.
Ophthalmic · 129d
Cleared Feb 17, 1989
QUIDEL FOOD ALLERGY SCREEN
K884501 · DHB
Quidel Corp.
Immunology · 114d
Cleared Feb 17, 1989
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
K884782 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 94d
Cleared Feb 17, 1989
O'NEIL URINARY CATHETER INTRODUCER
K884819 · KNY
Medical Marketing Group
Gastroenterology & Urology · 92d
Cleared Feb 17, 1989
KINEMAX TIBIAL WEDGE
K884837 · HRY
Howmedica Corp.
Orthopedic · 91d
Cleared Feb 17, 1989
HAND HELD NEBULIZER SYSTEM
K884947 · CAF
Salter Labs
Anesthesiology · 84d
Cleared Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Feb 17, 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · CIN
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Feb 17, 1989
HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275
K885079 · LPP
Mennen Medical, Inc.
Anesthesiology · 71d
Cleared Feb 17, 1989
EMIT THYROXINE ASSAY
K885141 · KLI
Syva Co.
Chemistry · 64d
Cleared Feb 17, 1989
AMYLASE SR LIQUID STABLE REAGENT SET
K885176 · JFJ
Medical Analysis Systems, Inc.
Chemistry · 65d
Cleared Feb 17, 1989
RMI SHORT DISTANCE ALIGNMENT DEVICE
K885223 · LNH
Radiation Measurements, Inc.
Radiology · 59d
Cleared Feb 17, 1989
TECHNICON AXON(TM) SYSTEM
K885226 · JJE
Technicon Instruments Corp.
Chemistry · 59d
Cleared Feb 17, 1989
ACA THYROXINE (T4 E) METHOD
K885258 · KLI
The DU Pont Co.
Chemistry · 56d
Cleared Feb 17, 1989
ACA THYRONINE UPTAKE (TU E) METHOD
K885259 · KHQ
The DU Pont Co.
Chemistry · 56d
Cleared Feb 17, 1989
DIGITRON 3, LV ANALYSIS PROTCOL
K885318 · LLZ
Siemens Gammasonics, Inc.
Radiology · 49d
Cleared Feb 17, 1989
HEMA(PRO)TEC(TION)
K885324 · GIO
Medical Products Search, Inc.
Hematology · 51d
Cleared Feb 17, 1989
BIOTROL CHLORIDE
K890015 · CHJ
Biotrol, USA, Inc.
Chemistry · 45d
Cleared Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · LBR
Sigma Diagnostics, Inc.
Chemistry · 44d