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
141961–141984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1986
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
K863168 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d
Cleared Oct 24, 1986
ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY
K863183 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 66d
Cleared Oct 24, 1986
UNITRON MODEL UL21 HEARING AID
K863225 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 24, 1986
DIRECT BILIRUBIN PROCEDURE
K863265 · CIG
Data Medical Associates, Inc.
Toxicology · 60d
Cleared Oct 24, 1986
VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS
K863386 · KOB
Angiomed U.S., Inc.
Gastroenterology & Urology · 51d
Cleared Oct 24, 1986
BLOOD SPECIMEN COLLECTION DEVICES
K863491 · JKA
Medelec Intl. Corp.
Chemistry · 46d
Cleared Oct 24, 1986
'TENSAID'
K863567 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 42d
Cleared Oct 24, 1986
'MYOSTIM EX'
K863568 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 42d
Cleared Oct 24, 1986
COATED SUTURE NEEDLE
K863595 · GAB
Sharpoint, Inc.
General & Plastic Surgery · 39d
Cleared Oct 24, 1986
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
K863617 · JGS
Hi Chem, Inc.
Chemistry · 38d
Cleared Oct 24, 1986
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K863680 · DZE
Interpore Intl.
Dental · 35d
Cleared Oct 24, 1986
ANTI-DNA MICROASSAY
K863717 · DHN
Diamedix Corp.
Immunology · 31d
Cleared Oct 24, 1986
BESCURE
K863739 · KNX
U-T, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 24, 1986
VALTRAC (BAR) REMOVER DEVICE
K863752 · EMF
Davis & Geck, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
2X2 SPONGES, NON-STERILE
K863760 · EFQ
The Medical Group, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
2X2 SPONGES, NON-STERILE, COTTON FILLED
K863761 · EFQ
The Medical Group, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
CONTOUR CUP MASKS
K863774
The Medical Group, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
B-WRAP
K863777
Bdf Plaza
General & Plastic Surgery · 28d
Cleared Oct 24, 1986
SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
K863824 · FKH
D.R.G. Scientific Industries
Gastroenterology & Urology · 24d
Cleared Oct 24, 1986
DEXTRA DISPOSABLE BLADES
K863867 · GES
Storz Instrument Co.
General & Plastic Surgery · 21d
Cleared Oct 24, 1986
GAUZE, NONABSORBABLE, NON-MEDICATED (INTERNAL)
K863870 · EFQ
Med-Tex, Inc.
General & Plastic Surgery · 21d
Cleared Oct 24, 1986
OPERATING ROOM TOWELS - STERILE/NON STERILE
K863871 · KKX
Med-Tex, Inc.
General Hospital · 21d
Cleared Oct 24, 1986
SABLE BLADES
K863885 · GES
Sable Industries
General & Plastic Surgery · 18d
Cleared Oct 24, 1986
GAUZE, ABSORBENT, STERILE, COMPRESSED
K863932 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 16d