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
156505–156528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1983
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · DBM
Zeus Scientific, Inc.
Microbiology · 50d
Cleared Jun 15, 1983
METAL-BACKED ACETABULAR CUP
K831479 · DXQ
Dow Corning Corp. Healthcare...
Cardiovascular · 37d
Cleared Jun 15, 1983
VARI-SUPPORT NECK POSTURE PILLOW
K831582 · IQK
Body Therapeutics, Inc.
Physical Medicine · 29d
Cleared Jun 15, 1983
INSTRUMENT GUARD CAPSULE
K831588 · KCT
Treace Medical, Inc.
General Hospital · 29d
Cleared Jun 15, 1983
T-TUBE INSERTER
K831590 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 15, 1983
CASTLE MODEL 3341 & 3441 & 4141 GAS AER
K831595 · FLI
Castle Co.
General Hospital · 29d
Cleared Jun 15, 1983
DROP FOOT BRACE
K831615 · IQI
Edward Dilauro, Jr.
Physical Medicine · 27d
Cleared Jun 14, 1983
BABY LIGHT METER
K837494
Rocky Mountain Medical Corp.
Radiology · 56d
Cleared Jun 14, 1983
INFRADIODE INFRARED LAMP
K837517
Phimo of Texas, Inc.
Radiology · 32d
Cleared Jun 13, 1983
REX PEDESTAL INTRA-ORAL X-RAY UNIT
K837491
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 74d
Cleared Jun 13, 1983
UNKNOWN
K837513
Xerox Corp.
Radiology · 49d
Cleared Jun 12, 1983
URINE SCREENING KIT
K830824 · CEN
Syn-Kit, Inc.
Microbiology · 89d
Cleared Jun 11, 1983
ETHICON EXTERNAL FIXATION WIRE
K821178 · FYI
Ethicon, Inc.
General & Plastic Surgery · 410d
Cleared Jun 10, 1983
EYELID SPECULUM
K830430 · HNC
Douglas C. Mckee & Co.
Ophthalmic · 121d
Cleared Jun 10, 1983
LENSERT CONTACT LENS CLEANING & INSERT
K830738 · KYE
Jermyn Specialties of California
Ophthalmic · 94d
Cleared Jun 10, 1983
RADIAL IMMUNODIFFUSION PLATES
K830911 · DDG
Biocell Laboratories, Inc.
Immunology · 81d
Cleared Jun 10, 1983
ACOH WELLNESS TESTER
K830954 · BZC
Bradley, Campbell & Carney
Anesthesiology · 77d
Cleared Jun 10, 1983
AUTO REFRACTOMETER
K831083 · HKO
Nidek, Inc.
Ophthalmic · 67d
Cleared Jun 10, 1983
LASER LAPARAXOPE
K831241 · HET
Eder Instrument Co, Inc.
Obstetrics & Gynecology · 56d
Cleared Jun 10, 1983
MICROSURGICAL KNIFE
K831266 · HNN
Vxtra Corp.
Ophthalmic · 53d
Cleared Jun 10, 1983
NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE
K831476 · BTQ
Fls Medical Products, Inc.
Anesthesiology · 32d
Cleared Jun 10, 1983
STRETCHER TOP TSI-107
K837413
Therapy Services, Inc.
Radiology · 52d
Cleared Jun 10, 1983
LASER PHOTOCOAGULATOR
K837422
Hgm, Inc.
Radiology · 49d
Cleared Jun 10, 1983
UNKNOWN
K837440
The S. S. White Co.
Radiology · 66d