FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135001–135024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1988
CAPTIA(R) SYPHILIS-G
K881425 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 121d
Cleared Aug 04, 1988
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · LYF
Meridian Diagnostics, Inc.
Microbiology · 114d
Cleared Aug 04, 1988
EMERSON CHEST RESPIRATOR, MODEL 33-CRE
K881808 · BYT
J. H. Emerson Co.
Anesthesiology · 98d
Cleared Aug 04, 1988
MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L
K881886 · IZO
U.S. Imaging, Inc.
Radiology · 91d
Cleared Aug 04, 1988
CATHETER, INTRAVASCULAR
K881976 · FOZ
Primrose Medical, Inc.
General Hospital · 85d
Cleared Aug 04, 1988
ETHYL ALCOHOL STANDARD
K882117 · DNN
Verichem Laboratories, Inc.
Toxicology · 77d
Cleared Aug 04, 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127 · FLL
Sheridan Catheter Corp.
General Hospital · 76d
Cleared Aug 04, 1988
TECHNICON DPA-1(TM) SYSTEM
K882153 · DCF
Technicon Instruments Corp.
Immunology · 73d
Cleared Aug 04, 1988
GEMINII GAMMA COUNTER
K882194 · JJE
Laboratory Technologies, Inc.
Toxicology · 71d
Cleared Aug 04, 1988
PHASE II LH KIT
K882252 · CEP
Vitek Systems, Inc.
Chemistry · 65d
Cleared Aug 04, 1988
CORONARY VEIN GRAFT MARKER
K882314 · DSY
Med-Edge, Inc.
Cardiovascular · 62d
Cleared Aug 04, 1988
LASER - 1000
K882436 · EHD
Panoramic Corp.
Radiology · 51d
Cleared Aug 04, 1988
FTI 200 MEDICAL THERMAL IMAGER
K882483 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 49d
Cleared Aug 04, 1988
ALTERNATE PROCEDURE, PHARMACIA IGE EIA
K882616 · JHR
Pharmacia, Inc.
Immunology · 41d
Cleared Aug 04, 1988
PHARMACIA IGE EIA ULTRA
K882626 · DGC
Pharmacia, Inc.
Immunology · 38d
Cleared Aug 04, 1988
OCU-FILM TIP COVER
K882750 · HKY
Oculab, Inc.
Ophthalmic · 30d
Cleared Aug 04, 1988
FIAGEN FERRITIN
K882822 · DFL
Cyberfluor, Inc.
Immunology · 27d
Cleared Aug 04, 1988
CIRCULATING IMMUNE COMPLEXES CONTROLS
K882829 · DAK
Cytotech, Inc.
Immunology · 27d
Cleared Aug 04, 1988
STORZ INFUSION CANNULA
K882884 · HMX
Storz Instrument Co.
Ophthalmic · 24d
Cleared Aug 04, 1988
QRK 100, QUALITATIVE RING KERATOSCOPE
K882902 · HLR
Technitex, Inc.
Ophthalmic · 23d
Cleared Aug 04, 1988
SONY VIDEO PRINTERS, UP SERIES
K882958 · KQM
Sony Medical Electronics Co.
General & Plastic Surgery · 21d
Cleared Aug 04, 1988
KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753
K882965 · KIT
Sigma Chemical Co.
Pathology · 20d
Cleared Aug 04, 1988
MEDIUM 199, CATALOG NO. 210-3535
K882983 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 04, 1988
MEDIUM 199, NO. 200-2035
K882984 · KIT
J R Scientific
Pathology · 20d