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
150361–150384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
K843201 · KFF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
HEPARIN CALIBRATOR ACA
K843202 · KFF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
LKB 2230 ROTARY ONE
K843505 · IDO
Lkb Instruments, Inc.
Pathology · 85d
Cleared Nov 30, 1984
LKB 2189 ULTROPROCESSOR
K843506 · IEO
Lkb Instruments, Inc.
Pathology · 85d
Cleared Nov 30, 1984
K-APATITE 20-40 MESH K-APATITE 40-60
K843557 · ELE
Katecho, Inc.
Dental · 81d
Cleared Nov 30, 1984
CAPILLARY BLOOD COLLECTION TUBE
K843608 · GIO
Medical Technomics, Ltd.
Hematology · 78d
Cleared Nov 30, 1984
I.V. PUMP ADMINISTRATION SET
K843949 · FRN
Travenol Laboratories, S.A.
General Hospital · 52d
Cleared Nov 30, 1984
MICROTENS 7757 T.E.N.S. STIMULATOR
K844017 · GFJ
Rabar, Inc.
General & Plastic Surgery · 46d
Cleared Nov 30, 1984
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
K844079 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 42d
Cleared Nov 30, 1984
GAINOR MEDICAL FLOWMAX NEEDLES
K844305 · FMI
Gainor Medical
General Hospital · 24d
Cleared Nov 30, 1984
GAINOR MEDICAL SYRINGE
K844306 · FMF
Gainor Medical
General Hospital · 24d
Cleared Nov 29, 1984
CASABLANCA
K841600 · HIS
Arcon Corp.
Obstetrics & Gynecology · 225d
Cleared Nov 29, 1984
MULTILITH 2 PULSE GENERATOR 1141 & 2141
K842220 · DXY
Ela Medical, Inc.
Cardiovascular · 177d
Cleared Nov 29, 1984
IREX 730 MECHANICAL SECTOR SCANNER
K842408 · JAF
Irex Corp.
Radiology · 163d
Cleared Nov 29, 1984
EVOKED POTENTIAL SYS
K842543 · GWF
Bio-Logic Systems Corp.
Neurology · 150d
Cleared Nov 29, 1984
AUTOFOCUS DUAL ELEMENT PROBE
K842777 · IYO
Technicare Corp.
Radiology · 136d
Cleared Nov 29, 1984
SURGEON'S GLOVES
K842884 · KGO
Travenol Laboratories, S.A.
General Hospital · 129d
Cleared Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
K843012 · DQX
Medi-Tech, Inc.
Cardiovascular · 121d
Cleared Nov 29, 1984
Q-SCAN THERMOGRAPHY SYSTEM
K843124 · KXZ
Qmax Medical, Inc.
Radiology · 113d
Cleared Nov 29, 1984
EPHAR
K843214 · FFI
Akron City Hospital
Gastroenterology & Urology · 106d
Cleared Nov 29, 1984
ZIMMER BONE CEMENT CENTRIFUGATION SYS
K843219 · JDZ
Zimmer, Inc.
Orthopedic · 106d
Cleared Nov 29, 1984
COROMETRICS 115 FETAL MONITOR
K843385 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 93d
Cleared Nov 29, 1984
3M LASER IMAGER
K843502 · LMC
3M Company
Radiology · 84d
Cleared Nov 29, 1984
FIRM-A-TRON MARK X
K843583 · IPF
Biotron , Ltd.
Physical Medicine · 79d