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

Filters: Cleared only ×
175,820 results
136921–136944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 07, 1988
MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
K880551 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Mar 04, 1988
NATURAL-TOUCH (TM) SURGEON'S GLOVE
K872996 · KGO
Hands-On Packaging , Ltd.
General Hospital · 214d
Cleared Mar 04, 1988
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
K874254 · LLO
Minnesota Laser Corp.
Anesthesiology · 136d
Cleared Mar 04, 1988
DISPOSABLE CAUTERIES
K874825 · GEI
Midsouth Industries, Inc.
General & Plastic Surgery · 100d
Cleared Mar 04, 1988
UMBILICAL ARTERY OXYGEN SENSOR
K875225 · CCE
Ohmeda Medical
Anesthesiology · 73d
Cleared Mar 04, 1988
STERILE EMPTY VIALS
K875227 · LDH
Allertech, Inc.
General Hospital · 73d
Cleared Mar 04, 1988
LUMBAR IMPACTION SET
K875290 · KWP
T. Korossurgical Instruments Corp.
Orthopedic · 65d
Cleared Mar 04, 1988
DAEWOO LATEX SURGICAL GLOVE
K880035 · KGO
California Ent.
General Hospital · 59d
Cleared Mar 04, 1988
BLADE, SURGICAL PREP RAZOR STRAIGHT
K880048 · LDQ
Crescent Corp.
General & Plastic Surgery · 58d
Cleared Mar 04, 1988
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
K880150 · HWE
Dyonics, Inc.
Orthopedic · 51d