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
133393–133416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1988
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
K884427 · BTO
Bivona Medical Technologies
Anesthesiology · 13d
Cleared Nov 01, 1988
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 245d
Cleared Nov 01, 1988
MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74
K881960 · FNL
Med Service, Inc.
General Hospital · 175d
Cleared Nov 01, 1988
MSI STANDARD BED MODELS: L1097-64 AND L1085-64
K881961 · FNJ
Med Service, Inc.
General Hospital · 175d
Cleared Nov 01, 1988
250 ML BAG W/Y INJECT. & 12 EXTENSION SET
K882598 · FRN
Prn Services, Inc.
General Hospital · 130d
Cleared Nov 01, 1988
TYMPANIC TEMPERATURE SCANNER
K882949 · FLL
Omega Medical Corp.
General Hospital · 110d
Cleared Nov 01, 1988
Q4000 OPTION FOR Q4000
K882978 · DSI
Quinton, Inc.
Cardiovascular · 109d
Cleared Nov 01, 1988
IRRIGATION SET
K883300 · HRX
Edwards Orthopaedics Div., Baxter...
Orthopedic · 89d
Cleared Nov 01, 1988
EP-100 INFUSION PUMP
K883653 · FRN
Stereotactic Medical Systems, Inc.
General Hospital · 67d
Cleared Nov 01, 1988
ORTHO FACTOR XII DEFICIENT PLASMA
K883688 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO OWREN'S BUFFER
K883689 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR X DEFICIENT PLASMA
K883690 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR XI DEFICIENT PLASMA
K883691 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR VII DEFICIENT PLASMA
K883692 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747 · CFT
Diagnostic Products Corp.
Chemistry · 61d
Cleared Nov 01, 1988
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
K883878 · CFT
Amersham Corp.
Chemistry · 49d
Cleared Nov 01, 1988
OMNISOUND(TM) 3000
K883893 · IMG
Physio Technology, Inc.
Physical Medicine · 48d
Cleared Nov 01, 1988
MODIFIED LANDMARK VENOUS ACCESS DEVICE
K884259 · FOZ
Menlo Care, Inc.
General Hospital · 28d
Cleared Nov 01, 1988
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
K884307 · LDR
Y
General Hospital · 19d
Cleared Nov 01, 1988
SONY COLOR VIDEO CAMERAS AND ACCESSORIES
K884343 · FWB
Sony Corp. of America
General & Plastic Surgery · 18d
Cleared Nov 01, 1988
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
K884357 · KOT
Precision Dynamics Corp.
Microbiology · 15d
Cleared Oct 31, 1988
SIEMENS PACS/I-A
K880690 · IZI
Siemens Gammasonics, Inc.
Radiology · 252d
Cleared Oct 31, 1988
COE PAK AUTO MIX, REGULAR OR HARD SET
K881422 · EMA
Coe Laboratories, Inc.
Dental · 209d
Cleared Oct 31, 1988
MEDITRON ENDOLAV MODEL EL-100
K882048 · KNS
Xylog Corp.
Gastroenterology & Urology · 168d