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
152257–152280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1984
EMIT D.A.U. URINE CANNABINOID ASSAY
K834458 · LDJ
Syva Co.
Toxicology · 185d
Cleared Jun 21, 1984
EMIT ST URINE CANNABINOID ASSAY
K841238 · LDJ
Syva Co.
Toxicology · 90d
Cleared Jun 19, 1984
UNIVERSAL SELF-ALIGNING ACETABULAR COM
K834035 · JDI
Orthopedic Equipment Co., Inc.
Orthopedic · 209d
Cleared Jun 19, 1984
UNIVERSAL PACK
K834155 · HQE
Atlantic Optical Systems, Inc.
Ophthalmic · 200d
Cleared Jun 19, 1984
Q-MED ELECTRODE
K840465 · DRX
Qmed, Inc.
Cardiovascular · 137d
Cleared Jun 19, 1984
MANUAL IRRIGATING/ASPIRATING UNIT
K840495 · HQC
Alltek, Inc.
Ophthalmic · 134d
Cleared Jun 19, 1984
TOCO DATA TELEPHONE TRANSMITTER DT100P
K840747 · HFM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 117d
Cleared Jun 19, 1984
CAT 100
K840836 · HKX
CooperVision, Inc.
Ophthalmic · 116d
Cleared Jun 19, 1984
CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD
K840955 · JEY
Synthes (Usa)
Dental · 106d
Cleared Jun 19, 1984
OCTOPUS 500/500E
K841099 · HPT
Cilco, Inc.
Ophthalmic · 99d
Cleared Jun 19, 1984
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · GQN
Syva Co.
Microbiology · 90d
Cleared Jun 19, 1984
ACCOMMOTRAC VISION TRAINER
K841273
Biofeedtrac, Inc.
Ophthalmic · 84d
Cleared Jun 19, 1984
MAC LEE VAGINAL IRRIGATOR
K841710 · HED
Mac Lee Medical Products
Obstetrics & Gynecology · 56d
Cleared Jun 19, 1984
WOODLYN CLASSIC INSTRUMENT STAND
K841760 · HRJ
Woodlyn, Inc.
Ophthalmic · 53d
Cleared Jun 19, 1984
OBSTETRICAL DOPPLER
K841805 · KNG
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 49d
Cleared Jun 19, 1984
AMER. MED. OPTICS ARGON LASER PHOTO
K841855 · HQF
American Medical Optics
Ophthalmic · 47d
Cleared Jun 19, 1984
6.5MM HEX HANDLE
K841969 · LXH
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
CAMELBACK HANDLE-K841969-LABELING
K841970 · LXH
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
2.5MM & 4MM PROBE K841969-LABELING
K841971 · HXB
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
BANANA KNIFE - K841969-LABELING
K841972 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
BANANA KNIFE SERRATED
K841973 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
RETROGRADE KNIFE 4MM & 5MM
K841974 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
ROSETTE KNIFE 4MM
K841975 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
HOOK KNIFE 4MM & 5MM
K841976 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d