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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94657–94680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 07, 1997
CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964492 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964495 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
SUTURE APPLICATOR
K964672 · GCJ
Laurus Medical Group
General & Plastic Surgery · 78d
Cleared Feb 07, 1997
MITRAFLEX PIGMENTED WOUND DRESSING
K964701 · FRO
Polymedica Industries, Inc.
General & Plastic Surgery · 74d
Cleared Feb 07, 1997
DELTA N95 RESPIRATOR
K964722 · FXX
Racal Filter Technologies, Inc.
General Hospital · 74d
Cleared Feb 07, 1997
RACAL N95 RESIRATOR
K964723 · FXX
Racal Filter Technologies, Inc.
General Hospital · 74d
Cleared Feb 07, 1997
KENDALL CURITY URETERAL CATHETER
K964899 · EYB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 66d
Cleared Feb 07, 1997
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE...
K964927 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 07, 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K964964 · LYZ
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 58d