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
143977–144000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1986
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427 · DSP
Kontron Instruments, Inc.
Cardiovascular · 92d
Cleared May 07, 1986
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K860586 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared May 07, 1986
EMIT COLUMN DIGOXIN CALIBRATORS
K861395 · DLJ
Syva Co.
Chemistry · 23d
Cleared May 06, 1986
PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD
K855084 · GEI
Conmedcorp
General & Plastic Surgery · 138d
Cleared May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237 · KHE
American Diagnostic Corp.
Hematology · 126d
Cleared May 06, 1986
MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT
K860277 · EWG
Britt Corp., Inc.
Ear, Nose, Throat · 99d
Cleared May 06, 1986
NEWPORT VENTILATOR MODEL E-100
K860438 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 91d
Cleared May 06, 1986
PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
K860442 · LPH
Howmedica Corp.
Orthopedic · 91d
Cleared May 06, 1986
STREAM LINE* I.V. CATHETER PLACEMENT UNIT
K860474 · FOZ
Menlo Care, Inc.
General Hospital · 88d
Cleared May 06, 1986
U - STAR (MICRO-STAR)
K860703 · LHI
Corning Costar Corp.
General Hospital · 69d
Cleared May 06, 1986
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · JWY
Gibco Laboratories Life Technologies,...
Microbiology · 68d
Cleared May 06, 1986
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · FMI
Icu Medical, Inc.
General Hospital · 64d
Cleared May 06, 1986
DUAL-AID
K860949 · CAE
Vitalograph , Ltd.
Anesthesiology · 55d
Cleared May 06, 1986
FLUID MANAGEMENT SYSTEM (MODIFIED)
K860969 · FRN
Haemonetics Corp.
General Hospital · 56d
Cleared May 06, 1986
SITE DISPOSABLE CASSETTE
K860989 · HQC
Microsurgical Systems, Inc.
Ophthalmic · 50d
Cleared May 06, 1986
KETA HAND-HELD TONOMETER
K861027 · HKS
Keta Corp.
Ophthalmic · 49d
Cleared May 06, 1986
E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
K861036 · GEI
Valleylab, Inc.
General & Plastic Surgery · 49d
Cleared May 06, 1986
SITE PHACO DISPOSABLE CASSETTE
K861060 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 47d
Cleared May 06, 1986
THE NEW FLEXIBLE COLLAPSIBLE CHAMBER
K861101 · KPJ
Stephenson Industries, Inc.
General & Plastic Surgery · 43d
Cleared May 06, 1986
EXEL VACUUM BLOOD COLLECTING SYSTEM
K861152 · FMI
Exel Intl.
General Hospital · 41d
Cleared May 06, 1986
XTAL X-800 SHADOWGRAPH
K861163
Xtal Corp.
Ophthalmic · 39d
Cleared May 06, 1986
NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES
K861288 · KKX
Procedure Pak, Inc.
General Hospital · 29d
Cleared May 06, 1986
FASICULATED NAIL
K861365 · HSB
Lake Region Mfg., Inc.
Orthopedic · 25d
Cleared May 06, 1986
PRE-CHECK C02 DETECTOR
K861398 · CCK
Alleghany Intl. Medical Technology
Anesthesiology · 21d