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
130057–130080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1989
J&S IRON SATURATING REAGENTS
K893662 · JMO
J.S. Medical Assoc.
Chemistry · 66d
Cleared Jul 20, 1989
RMS 180
K893673 · IXR
Fischer Imaging Corp.
Radiology · 66d
Cleared Jul 20, 1989
RME 325R
K893674 · IZO
Fischer Imaging Corp.
Radiology · 66d
Cleared Jul 20, 1989
MAMM-AIRE CP
K893681 · IZO
Custom Medical Products, Ltd.
Radiology · 65d
Cleared Jul 20, 1989
VISION INTEGRATED PERFORMANCE OPTION
K893689 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jul 20, 1989
SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)
K893690 · IXQ
Hofmann X-Ray of America, Inc.
Radiology · 65d
Cleared Jul 20, 1989
CENTRICON CONCENTRATOR
K893733 · JJH
Amicon, Inc.
Chemistry · 64d
Cleared Jul 20, 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jul 20, 1989
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
K893765 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jul 20, 1989
2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
K894053 · CCK
Fenem, Inc.
Anesthesiology · 43d
Cleared Jul 19, 1989
POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
K890132 · JWH
Richards Medical Co., Inc.
Orthopedic · 188d
Cleared Jul 19, 1989
SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4
K890963 · IYO
Esaote Biomedica Elettronica
Radiology · 142d
Cleared Jul 19, 1989
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
K892059 · LZY
Protek, Inc.
Orthopedic · 112d
Cleared Jul 19, 1989
POROUS GENESIS STEMMED TIBIAL COMPONENT
K892366 · JWH
Richards Medical Co., Inc.
Orthopedic · 104d
Cleared Jul 19, 1989
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
K892394 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 103d
Cleared Jul 19, 1989
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
K892944 · JOP
Interspec, Inc.
Cardiovascular · 89d
Cleared Jul 19, 1989
CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM
K893042 · IYN
Endosonics Corp.
Radiology · 86d
Cleared Jul 17, 1989
BIOPSY KIT
K892389 · LRO
I M, Inc.
General & Plastic Surgery · 101d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870 · LSE
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
K883871 · LSE
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
NEUROTRAIN
K883896 · LIH
Sterne Equipment Co., Ltd.
Neurology · 303d
Cleared Jul 14, 1989
SURGICAL GLOVES
K884495 · KGO
Sanko Chemical Industry Co., Ltd.
General Hospital · 275d
Cleared Jul 14, 1989
BASAL/BOLUS INFUSORS
K884505 · FRN
Baxter Healthcare Corp
General Hospital · 262d
Cleared Jul 14, 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · DSF
Datex Division Instrumentarium Corp.
Cardiovascular · 219d