FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95161–95184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
K964812 · FPA
Critical Device Corp.
General Hospital · 73d
Cleared Feb 10, 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Feb 10, 1997
TROPONIN-I TEST SYSTEM
K964862 · MMI
Dade Intl., Inc.
Chemistry · 68d
Cleared Feb 10, 1997
WHITE CORE
K964931 · EBF
Bisco, Inc.
Dental · 62d
Cleared Feb 10, 1997
ROUND DENTAL BUR
K964944 · DZE
Steri-Oss, Inc.
Dental · 62d
Cleared Feb 10, 1997
TEMPFIL C&B
K964981 · EBG
Sybron Dental Specialties, Inc.
Dental · 60d
Cleared Feb 10, 1997
PFINGST PRESSURE PASTE
K965026 · EFH
Pfingst & Co., Inc.
Dental · 55d
Cleared Feb 10, 1997
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Feb 10, 1997
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K965213 · DDR
Dade Intl., Inc.
Immunology · 42d
Cleared Feb 10, 1997
TANDEMRX
K970054 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 34d
Cleared Feb 10, 1997
ELECSYS CALCHECK PROLACTIN
K970147 · JJY
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Feb 10, 1997
ELECSYS CALCHECK ESTRADIOL
K970148 · JJX
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Feb 10, 1997
SEIRIN PYONEX ACUPUNCTURE NEEDLES
K970254 · MQX
Seirin-America, Inc.
General Hospital · 19d
Cleared Feb 10, 1997
SEIRIN JR ACUPUNCTURE NEEDLES
K970260 · MQX
Seirin-America, Inc.
General Hospital · 18d
Cleared Feb 07, 1997
RIGID FIBER OPTIC LAPAROSCOPE
K962246 · HET
Health Care International Assoc.
Obstetrics & Gynecology · 241d
Cleared Feb 07, 1997
FEMEXAM TESTCARD
K962718 · CEN
Litmus Concepts, Inc.
Chemistry · 210d
Cleared Feb 07, 1997
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
K962737 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 207d
Cleared Feb 07, 1997
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K963023 · FDS
Olympus America, Inc.
Radiology · 186d
Cleared Feb 07, 1997
PATIENT EXAMINATION GLOVES
K964148 · LZA
Hartalega Sdn Bhd
General Hospital · 114d
Cleared Feb 07, 1997
REMEL STAPH LATEX KIT
K964315 · JWX
Remel, L.P.
Microbiology · 101d
Cleared Feb 07, 1997
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964487 · JTN
Unipath , Ltd.
Microbiology · 92d
Cleared Feb 07, 1997
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964490 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964491 · JTN
Unipath , Ltd.
Microbiology · 92d