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
153697–153720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1984
FPP IV SECURE
K840683 · KMK
Fpp, Inc.
General Hospital · 20d
Cleared Mar 06, 1984
LASER MIRROR
K840982
American V. Mueller
Ophthalmic
Cleared Mar 05, 1984
SUTURE-AID BOOTIES
K832441 · KDC
Omega-Med Intl., Inc.
General & Plastic Surgery · 224d
Cleared Mar 05, 1984
MODEL MK II TENS
K833251 · GZJ
European Electronic Systems, Ltd.
Neurology · 164d
Cleared Mar 05, 1984
DOWING OPHTHALMIC CHAIR-NON/AC POWER
K833538 · HMD
Vision Health Technology
Ophthalmic · 152d
Cleared Mar 05, 1984
DOWING OPHTHALMIC CHAIR AC-POWERED
K833539 · HME
Vision Health Technology
Ophthalmic · 152d
Cleared Mar 05, 1984
PHAKO SYSTEMS VIA 2000
K833642 · HQC
Pharosystems, Inc.
Ophthalmic · 140d
Cleared Mar 05, 1984
DISPOS. I/A & IRRIGATION HANDPIECES
K833783 · HQC
CooperVision, Inc.
Ophthalmic · 129d
Cleared Mar 05, 1984
MODEL IV 100B-DA INFANT VENTILATOR
K833982 · CBK
Sechrist Industries, Inc.
Anesthesiology · 109d
Cleared Mar 05, 1984
JAKOBI SURG. INSTRUMENTS #6 50
K834187 · HKY
Imm Enterprises , Ltd.
Ophthalmic · 105d
Cleared Mar 05, 1984
TCT-1 TREATMENT COUCH
K834201 · JAI
Therados, Inc.
Radiology · 91d
Cleared Mar 05, 1984
STRATUS TOTAL THYROXINE FLUOROMETRIC
K834210 · KLI
American Dade
Chemistry · 91d
Cleared Mar 05, 1984
BOUNDARY REINFORCED SINGLE-USE GOWNS
K834339
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 84d
Cleared Mar 05, 1984
ABSORBENT INCONTINENT PADS & BRIEFS
K834359 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 83d
Cleared Mar 05, 1984
JSB JET SYRINGE
K834361 · EGM
C.B.S. Biotechnics, Inc.
Dental · 130d
Cleared Mar 05, 1984
SURGICAL DISPOSABLE STERILE & NONSTERIL
K834368 · FMF
Marbex, Inc.
General Hospital · 75d
Cleared Mar 05, 1984
DIGI-X
K834483 · LHO
Radiation Measurements, Inc.
Radiology · 90d
Cleared Mar 05, 1984
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
K834570 · BZO
Airlife, Inc.
Anesthesiology · 67d
Cleared Mar 05, 1984
AQUA TRAP
K834573 · BYH
Airlife, Inc.
Anesthesiology · 67d
Cleared Mar 05, 1984
WILCOR-XR RP MEDICAL FILM
K834613 · IWZ
Cea America Corp.
Radiology · 76d
Cleared Mar 05, 1984
WILCOR-XR RP-L MEDICAL FILM
K834614 · IWZ
Cea America Corp.
Radiology · 76d
Cleared Mar 05, 1984
SDI PREPAX DILUKIT HW
K840041 · GIF
Scientific Distributors, Inc.
Hematology · 59d
Cleared Mar 05, 1984
SKIN STAPLE REMOVER
K840089
Mediquest, Inc.
General & Plastic Surgery · 55d
Cleared Mar 05, 1984
APPOSE ULE STERILE DISPOS. SKIN STAP
K840177 · GAG
Davis & Geck, Inc.
General & Plastic Surgery · 48d