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
136321–136344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1988
O.P.C. INTRAVASCULAR CATHETER
K875082 · FOZ
Taut, Inc.
General Hospital · 90d
Cleared Mar 08, 1988
MENTOR B-VAT(TM) II VIDEO TESTER
K875112 · HOX
Mentor O & O, Inc.
Ophthalmic · 84d
Cleared Mar 08, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS
K880024 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 63d
Cleared Mar 08, 1988
NUTRIENT BROTH
K880114 · JSG
Hardy Media
Microbiology · 62d
Cleared Mar 08, 1988
NUTRIENT GELATIN
K880115 · JSF
Hardy Media
Microbiology · 62d
Cleared Mar 08, 1988
DYNATRON II
K880464 · LBB
Dynatronics Laser Corp.
Neurology · 34d
Cleared Mar 07, 1988
ACRYLIC IMPRESSION TRAY MATERIALS
K873739 · EBH
E&D Dental Manufacturing Co.
Dental · 174d
Cleared Mar 07, 1988
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
K873853 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 167d
Cleared Mar 07, 1988
SIMED S-100 PULSE OXIMETER
K873896 · DQA
Simed
Anesthesiology · 187d
Cleared Mar 07, 1988
MONITOR, ELECTROGRAPHIC
K874319 · DRT
Medac, Inc.
Cardiovascular · 138d
Cleared Mar 07, 1988
MENTOR PLUS (CONDOM)
K874383 · HIS
Arcon Corp.
Obstetrics & Gynecology · 133d
Cleared Mar 07, 1988
TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
K874542 · DQX
Toray Industries (America), Inc.
Cardiovascular · 125d
Cleared Mar 07, 1988
TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
K874594 · LGD
Clinical Sciences, Inc.
Microbiology · 119d
Cleared Mar 07, 1988
INTERFERENCE SCREW
K874676 · HWC
Concept, Inc.
Orthopedic · 115d
Cleared Mar 07, 1988
DETECTADOT SYSTEM 2000 TOXO IGG TEST
K875109 · LGD
Gull Laboratories, Inc.
Microbiology · 84d
Cleared Mar 07, 1988
OPHTHALMIC LIGHT PIPE PICK
K875195 · FST
Trek Medical Products, Inc.
General & Plastic Surgery · 81d
Cleared Mar 07, 1988
502-US PULSE OXIMETER
K875298 · DQA
Criticare Systems, Inc.
Anesthesiology · 68d
Cleared Mar 07, 1988
DEGUSTAR
K880033 · EJT
Degussa Dental, Inc.
Dental · 62d
Cleared Mar 07, 1988
BIOMA 5000
K880036 · DRG
E.B.S., Inc.
Cardiovascular · 62d
Cleared Mar 07, 1988
C-MATE #CMU 1001
K880062 · HQC
O.R. Specialties, Inc.
Ophthalmic · 60d
Cleared Mar 07, 1988
EFFERVESCENT DENTURE CLEANSER
K880068 · EFT
Perrigo Co.
Dental · 56d
Cleared Mar 07, 1988
POTATO DEXTROSE AGAR
K880127 · KZI
Hardy Media
Microbiology · 61d
Cleared Mar 07, 1988
MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID
K880224 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 47d
Cleared Mar 07, 1988
MODEL 759 CUSTOM IN-THE-EAR HEARING AID
K880349 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 41d