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
160849–160872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1982
SILOAM SAVE-A-NEEDLE
K820502 · GAA
Siloam, Inc.
General & Plastic Surgery · 18d
Cleared Mar 15, 1982
CHORIO-QUANT
K820523 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 17d
Cleared Mar 15, 1982
RAICHEM GPT (ALT) REAGENT
K820525 · CKA
Reagents Applications, Inc.
Chemistry · 17d
Cleared Mar 15, 1982
RELIEVED REINFORCED CUP
K820539 · DXQ
Biomet, Inc.
Cardiovascular · 13d
Cleared Mar 15, 1982
POWERED TREADMILL
K820548 · IOL
Ogden Health Products
Physical Medicine · 13d
Cleared Mar 15, 1982
MECHANICAL CHAIR
K820591 · LBE
Kaye Products, Inc.
Physical Medicine · 11d
Cleared Mar 12, 1982
EAST AUTOCLAVE HUMIDIFIER
K812957 · BTT
Cairco , Ltd.
Anesthesiology · 142d
Cleared Mar 12, 1982
DISP. HYPERINFLATION BAG SYSTEM
K813317 · NHK
Intec Medical, Inc.
Anesthesiology · 108d
Cleared Mar 12, 1982
THERMASCAN
K813547 · KXZ
Bcd Products, Inc.
Radiology · 81d
Cleared Mar 12, 1982
PERMANENT & TEMPORARY PACEMAKER ELECTR.
K820262 · DTB
Diag Corp.
Cardiovascular · 38d
Cleared Mar 12, 1982
CLINIFLOW II, #701, ELECTROMAGN. BLD. SY
K820272 · DPW
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Mar 12, 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · DTL
C.R. Bard, Inc.
Cardiovascular · 36d
Cleared Mar 12, 1982
MONITRON MODEL JL-7
K820353 · CAP
Florida Medical Equipment Repair, Inc.
Anesthesiology · 32d
Cleared Mar 12, 1982
ANESTHESIA VENTILATOR
K820393 · CBK
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared Mar 12, 1982
PATIENT FOLLOW-UP COMPUTER (PFC
K820402 · DXN
Medical Systems, Inc.
Cardiovascular · 28d
Cleared Mar 12, 1982
AEGIS NON-ADHERENT DRESSING
K820413 · NAB
Professional Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Mar 12, 1982
IMPACT, MODEL 310
K820424 · GCX
Impact Instrumentation, Inc.
General Hospital · 24d
Cleared Mar 12, 1982
HEART-ALERT
K820444 · KHX
Medical Equipment Devices, Inc.
Physical Medicine · 22d
Cleared Mar 12, 1982
PHARMACEUTICALS MOD. 1CC-1,2,3 THRU 50CC
K820449 · FMF
Abek Corp.
General Hospital · 22d
Cleared Mar 12, 1982
MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS
K820457 · DRS
Graphic Controls Corp.
Cardiovascular · 21d
Cleared Mar 11, 1982
MONO-POLY RESOLVING MEDIUM
K812947 · JCF
Flow Laboratories, Inc.
Hematology · 142d
Cleared Mar 11, 1982
ZEON COMPOSITE RESIN LIGHT CURE SYS
K820028 · EBF
National Patent Development Corp.
Dental · 65d
Cleared Mar 11, 1982
ANTERIOR DISTRACTION SYSTEM
K820034 · KWQ
Stuart
Orthopedic · 66d
Cleared Mar 11, 1982
ENDOSSEOUS SCREW IMPLANT
K820163 · DZE
General A. Nitznick, D.M.D.
Dental · 50d