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
121153–121176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1991
AVI MODEL 870 DUAL CHANNEL INFUSION PUMP
K912031 · FRN
3M Avi, Inc.
General Hospital · 41d
Cleared Jun 18, 1991
DISTENDABLE PALPATION PROBE
K912343 · GCJ
Dexide, Inc.
General & Plastic Surgery · 21d
Cleared Jun 17, 1991
TITAN TOTAL HIP DEVICE
K905298 · JDI
Dr. Jean-Marc Guichet
Orthopedic · 202d
Cleared Jun 17, 1991
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
K905306 · GRC
Virion (U.S.), Inc.
Microbiology · 201d
Cleared Jun 17, 1991
CENTAURI/PEGASUS
K905737 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 175d
Cleared Jun 17, 1991
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K905754 · CBS
Datex Division Instrumentarium Corp.
Anesthesiology · 175d
Cleared Jun 17, 1991
LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL
K910434 · BTL
Life Corp.
Anesthesiology · 137d
Cleared Jun 17, 1991
LIFE OXYGENPAC 6/12 LPM
K910435 · BTL
Life Corp.
Anesthesiology · 137d
Cleared Jun 17, 1991
QM300 CALIBRATOR G PACK
K910885 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 CONTROL G PACK
K910887 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
NEXUS(TM) FEMORAL HIP STEM
K911052 · JDI
Dow Corning Wright
Orthopedic · 101d
Cleared Jun 17, 1991
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
K911078 · KPS
Siemens Gammasonics, Inc.
Radiology · 98d
Cleared Jun 17, 1991
SI-1200 / ILUS
K911200 · IYO
Siemens Ultrasound, Inc.
Radiology · 90d
Cleared Jun 17, 1991
ARTHROSCOPY INSTRUMENT CANNULA
K911205 · HRX
Davol, Inc.
Orthopedic · 90d
Cleared Jun 17, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
K911280 · IZO
Shimadzu Medical Systems
Radiology · 84d
Cleared Jun 17, 1991
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 82d
Cleared Jun 17, 1991
COULTER(R) MH010
K911385 · GKZ
Coulter Electronics, Inc.
Hematology · 81d
Cleared Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · HKI
Canon USA, Inc.
Ophthalmic · 76d
Cleared Jun 17, 1991
MAGNA SURGEONS GOWNS
K911508 · FYA
Dms Miami, Inc.
General Hospital · 75d
Cleared Jun 17, 1991
MAGNA OBSTETRICAL PACKS
K911509 · KKX
Dms Miami, Inc.
General Hospital · 75d
Cleared Jun 17, 1991
MAGNA SURGICAL PACKS
K911510 · KKX
Dms Miami, Inc.
General Hospital · 75d
Cleared Jun 17, 1991
INTRASITE HYDROCOLLOID WOUND DRESSING
K911660 · MGP
Smith & Nephew United, Inc.
General & Plastic Surgery · 66d
Cleared Jun 17, 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · EMA
3M Company
Dental · 53d