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
144409–144432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1986
DIGITAL-9 KEY LEUCOCYTE COUNTER
K854685 · GKM
Future Impex Corp.
Hematology · 135d
Cleared Apr 04, 1986
MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI
K854833 · GEX
Meditec, Inc.
General & Plastic Surgery · 126d
Cleared Apr 04, 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 114d
Cleared Apr 04, 1986
KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE
K855086 · ITI
Kempf Co.
Physical Medicine · 105d
Cleared Apr 04, 1986
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
K860122 · JBP
Medical Device Consultants, Inc.
Hematology · 80d
Cleared Apr 04, 1986
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
K860166 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared Apr 04, 1986
GUNKEL CHROMAGRAPH COLOR VISION TESTER
K860174 · HIW
Chromagraphics, Inc.
Ophthalmic · 77d
Cleared Apr 04, 1986
KULTSURE (CULTURE TRANSPORT)
K860178 · JSM
Ncs Diagnostics, Inc.
Microbiology · 77d
Cleared Apr 04, 1986
UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER
K860185 · GZB
Neuromed, Inc.
Neurology · 73d
Cleared Apr 04, 1986
KYOCERA BIOCERAM POROUS DENTAL IMPLANT
K860360 · DZE
Kyocera International, Inc.
Dental · 64d
Cleared Apr 04, 1986
ASSERACHROM VWF KIT
K860371 · GGP
American Bioproducts Co.
Hematology · 60d
Cleared Apr 04, 1986
CLAMP-N-CUT
K860445 · HFW
Mmi, Inc.
Obstetrics & Gynecology · 59d
Cleared Apr 04, 1986
FILTRA-CHECK-UTI
K860483 · JXA
Applied Polytechnology, Inc.
Microbiology · 53d
Cleared Apr 04, 1986
36-101 XDS111 XENON DELIVERY/TRAP SYSTEM
K860504 · ITY
Victoreen, Inc.
Radiology · 52d
Cleared Apr 04, 1986
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · KYG
Staar Surgical Co.
Ophthalmic · 50d
Cleared Apr 04, 1986
MUREX SUDS GROUP A STREP
K860576 · GTZ
Murex Corp.
Microbiology · 45d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · GTZ
Hybritech, Inc.
Microbiology · 32d
Cleared Apr 04, 1986
URICHECK
K860905 · JXA
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Apr 04, 1986
EYEMETER
K860928
Indivisual Corporation, Inc.
Ophthalmic · 24d
Cleared Apr 04, 1986
ABSORBENT, FIBER, OPERATING ROOM TOWELS
K860936 · KKX
Ulti-Med Intl., Inc.
General Hospital · 23d
Cleared Apr 04, 1986
VIRTRAN VIRAL TRANSPORTER (MODIFIED)
K860967 · JSN
Diagnon Corp.
Microbiology · 25d
Cleared Apr 04, 1986
DONALDSON NATURAL EYEPATCH
K860979 · HMP
Keeler Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Apr 04, 1986
SILENT PARTNER MODEL 10-2001
K861011 · CAW
Medical Devices, Inc.
Anesthesiology · 17d
Cleared Apr 04, 1986
SILENT PARTNER MODEL 10-1001
K861012 · CAW
Medical Devices, Inc.
Anesthesiology · 17d