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
108361–108384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1994
COMFEEL PLUS WOUND DRESSING
K941263 · KMF
Richard Hamer Assoc., Inc.
General & Plastic Surgery · 55d
Cleared May 10, 1994
VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC
K941968 · GEI
Valleylab, Inc.
General & Plastic Surgery · 18d
Cleared May 09, 1994
AUTOMATIC NEEDLE DISCONECT (A.N.D.)
K925086 · FMI
Post Medical, Inc.
General Hospital · 579d
Cleared May 09, 1994
ISOFLUX IXP FLOW REGULATOR
K925731 · FPA
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
ISOFLUX IXZ FLOW REGULATOR
K925732 · FPA
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
ISOFLUX IXL FLOW REGULATOR
K925733 · FPA
Ferguson Medical
General Hospital · 542d
Cleared May 09, 1994
PRIMUS PSS SERIES STERILIZERS
K926185 · FLE
Primus Sterilizer Co., Inc.
General Hospital · 517d
Cleared May 09, 1994
EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER
K926560 · JAA
Fischer Imaging Corp.
Radiology · 494d
Cleared May 09, 1994
SELECT(R) SHOULDER ALL-POLY GLENOID
K931114 · KWT
Intermedics Orthopedics
Orthopedic · 431d
Cleared May 09, 1994
MICROARCH GOLD BRACKET
K932825 · EJF
Gac Intl., Inc.
Dental · 334d
Cleared May 09, 1994
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 201d
Cleared May 09, 1994
INSTRU KLENZ
K935063 · FLG
Calgon Corp.
General Hospital · 200d
Cleared May 09, 1994
COMFIT
K935464 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 178d
Cleared May 09, 1994
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K935864 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 157d
Cleared May 09, 1994
URINARY ALBUMIN TEST PACK
K936202 · JIQ
Dupont Medical Products
Chemistry · 131d
Cleared May 09, 1994
GLYCATED PROTEIN CALIBRATORS
K940008 · JIS
Primus Corp.
Hematology · 125d
Cleared May 09, 1994
PAFLUFOCON A, B, C & D
K940277 · HQD
Paragon Vision Sciences
Ophthalmic · 110d
Cleared May 09, 1994
SIME SURGICAL LATEX GLOVE
K940797 · KGO
Sime Health, Ltd.
General Hospital · 76d
Cleared May 09, 1994
CON-KIT
K941129 · LKS
Medical Chemical Corp.
Microbiology · 61d
Cleared May 09, 1994
FITIPALDI DRIVING SUNGLASSES
K941415 · HQY
L'Equipe Visual, Inc.
Ophthalmic · 47d
Cleared May 09, 1994
I CARE
K941442 · HQY
I Care Intl., Inc.
Ophthalmic · 46d
Cleared May 09, 1994
SUNGLASSES
K941529 · HQY
Wesearch, Inc.
Ophthalmic · 40d
Cleared May 09, 1994
SUNGLASSES
K941680 · HQY
Walmart Stores
Ophthalmic · 34d
Cleared May 09, 1994
POWDER FREE LATEX EXMINATION GLOVES
K941754 · LYY
Sj Medical Products (M) Sdn Bhd
General Hospital · 31d