FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126169–126192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1990
SUNGLASS, NON-PRESCRIPTION
K900764 · HQY
Seiko Optical Products of America, Inc.
Ophthalmic · 120d
Cleared Jun 20, 1990
ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE
K901134 · KNT
Fresenius Pharma
Gastroenterology & Urology · 100d
Cleared Jun 20, 1990
ASI HEMOSTASIS CATHETER
K901336 · GBM
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 20, 1990
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.
K901397 · MCC
Gen-Probe, Inc.
Microbiology · 86d
Cleared Jun 20, 1990
CONTINUUM KNEE SYSTEM (CKS)
K901457 · JWH
Techmedica, Inc.
Orthopedic · 84d
Cleared Jun 20, 1990
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475 · CDX
Baxter Healthcare Corp
Chemistry · 85d
Cleared Jun 20, 1990
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
K901481 · GEX
Nidek, Inc.
General & Plastic Surgery · 83d
Cleared Jun 20, 1990
PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
K901531 · DNP
Pioneering Technologies, Inc.
Toxicology · 90d
Cleared Jun 20, 1990
SUNGLASSES STYLE #(1137)
K901570 · HQY
Zaks Stores, Inc.
Ophthalmic · 78d
Cleared Jun 20, 1990
SUNGLASSES STYLE #(CM-1989)
K901571 · HQY
Zaks Stores, Inc.
Ophthalmic · 78d
Cleared Jun 20, 1990
CANNULATED INTERFERENCE SCREW SYSTEM
K901616 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 75d
Cleared Jun 20, 1990
ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
K901735 · HRX
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 64d
Cleared Jun 20, 1990
DRYSLIDE, BETA-LACTAMASE
K901784 · JTO
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Jun 20, 1990
MICROMATE 196 MODEL A961960
K901808 · JTC
Packard Instrument Co., Inc.
Microbiology · 61d
Cleared Jun 20, 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · LJC
Eastman Kodak Company
Microbiology · 51d
Cleared Jun 20, 1990
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K902010 · KGX
Visitec Co.
General & Plastic Surgery · 48d
Cleared Jun 20, 1990
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
K902028 · JPI
Norfolk Scientific, Inc.
Hematology · 47d
Cleared Jun 20, 1990
ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
K902168 · HRX
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 36d
Cleared Jun 20, 1990
AMCATH COAGULATION PROBE
K902555 · HFG
Intl. Medical, Inc.
Obstetrics & Gynecology · 12d
Cleared Jun 20, 1990
REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER
K902562 · GEX
Lca, Inc.
General & Plastic Surgery · 9d
Cleared Jun 19, 1990
PULSE OXIMETRY MODULE
K901071 · DQA
Marquette Electronics, Inc.
Anesthesiology · 104d
Cleared Jun 19, 1990
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · HIS
Carter Products
Obstetrics & Gynecology · 99d
Cleared Jun 19, 1990
SUNGLASSES STYLE #(70116)
K901572 · HQY
Zaks Stores, Inc.
Ophthalmic · 77d
Cleared Jun 19, 1990
COLORADO COLOR IMAGING RECORDER
K902230 · DSF
Honeywell, Inc.
Cardiovascular · 33d