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
123817–123840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1990
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · CAW
Invacare Corp.
Anesthesiology · 52d
Cleared Oct 26, 1990
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099 · JJY
Hichem Diagnostics
Chemistry · 50d
Cleared Oct 26, 1990
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
K904221 · CAK
Baxter Healthcare Corp
General Hospital · 43d
Cleared Oct 26, 1990
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
K904223 · CAK
Baxter Healthcare Corp
General Hospital · 43d
Cleared Oct 26, 1990
RECEIVING BLANKET
K904274 · KME
Anago, Inc.
General Hospital · 38d
Cleared Oct 26, 1990
DUPONT DRUG CLIBRATOR-B
K904303 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 26, 1990
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 26, 1990
BIOCLONES ELEGANCE FSH ELISA KIT
K904405 · CGJ
Bioclone Australia Pty , Ltd.
Chemistry · 31d
Cleared Oct 26, 1990
METER TRAX
K904461 · JPK
Hematronix, Inc.
Chemistry · 25d
Cleared Oct 26, 1990
BAXTER SINGLE PATIENT USE PRESSURE INFUSOR
K904484 · KZD
Tecnadyne Scientific, Inc.
General Hospital · 24d
Cleared Oct 26, 1990
VIDEO SYSTEM INTERFACE MODELS
K904540 · IZI
Perkins Mfg. Co.
Radiology · 22d
Cleared Oct 26, 1990
POST MYDRIATIC SPECTACLES
K904585 · HQY
Yorktowne Optical Co., Inc.
Ophthalmic · 17d
Cleared Oct 26, 1990
POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES
K904720 · HRX
Baxter Healthcare Corp
Orthopedic · 8d
Cleared Oct 26, 1990
AMPRO LATEX EXAM GLOVE
K904740 · LYY
American Pro Latex, Inc.
General Hospital · 8d
Cleared Oct 25, 1990
ORION WATCHGUARD
K902104 · HFM
Orion Industries
Obstetrics & Gynecology · 170d
Cleared Oct 25, 1990
STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE
K903029 · GAR
Look, Inc.
General & Plastic Surgery · 107d
Cleared Oct 25, 1990
SUPRAMID EXTRA SUTURES
K904052 · GAR
S. Jackson, Inc.
General & Plastic Surgery · 57d
Cleared Oct 24, 1990
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
K901549 · GWQ
Cns, Inc.
Neurology · 204d
Cleared Oct 24, 1990
PALLADIUS-V AND PALLADIUS-AG SEMI-PRECIOUS ALLOY
K902863 · EJT
Vident
Dental · 118d
Cleared Oct 24, 1990
AMPLAID 770 ADMITTANCE METER
K903066 · ETY
Amplus Corp.
Ear, Nose, Throat · 104d
Cleared Oct 24, 1990
A-DEC DECADE 1015 CHAIR
K903450 · KLC
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC PAC I PORTABLE UNIT
K903451 · EIA
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC IC CONTROL HEAD
K903452 · EIA
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC IC MICRO-CART
K903453 · EIA
A-Dec, Inc.
Dental · 85d