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
111265–111288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1993
SUNGLASSES
K930585 · HQY
Daiko S.R.L.
Ophthalmic · 281d
Cleared Nov 12, 1993
GOGGLE SAFEGUARD
K931254 · HOY
Sellstrom Mfg. Co.
Ophthalmic · 245d
Cleared Nov 12, 1993
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
K931866 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 212d
Cleared Nov 12, 1993
TOTE-L-VAC
K932051 · BTA
Aeros Instruments, Inc.
General & Plastic Surgery · 199d
Cleared Nov 12, 1993
JR -- OPHTHALMIC ARGON LASER
K932296 · HQF
Carson Laserworks
Ophthalmic · 185d
Cleared Nov 12, 1993
HANAULUX 2005 SURGICAL LIGHT
K932451 · FTD
Heraeus Instruments GmbH
General & Plastic Surgery · 176d
Cleared Nov 12, 1993
PRESSUREGUARD IV
K932681 · FNM
Span-America Medical Systems, Inc.
General Hospital · 162d
Cleared Nov 12, 1993
NITI ARCH WIRE ON A SPOOL
K933376 · DZC
Highland Metals
Dental · 126d
Cleared Nov 12, 1993
REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER
K933378 · DZC
Highland Metals
Dental · 126d
Cleared Nov 12, 1993
STAINLESS STEEL ARCHES
K933379 · DZC
Highland Metals
Dental · 126d
Cleared Nov 12, 1993
REVERSE SURVE NITI ARCH WIRE
K933380 · DZC
Highland Metals
Dental · 126d
Cleared Nov 12, 1993
MANAN ADAPTER FOR BIP BIOPSY DEVICE
K933448 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Nov 12, 1993
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
K933645 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 108d
Cleared Nov 12, 1993
INSTRUMENT ACTUATING DEVICE (IAD)
K933720 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 102d
Cleared Nov 12, 1993
MICROWAVE INSURG INTRODUCER
K933985 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 88d
Cleared Nov 12, 1993
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085 · HOY
American Threshold Industries, Inc.
Ophthalmic · 84d
Cleared Nov 12, 1993
NUCLEAR ASSOCIATES GLASSERS
K934362 · IWS
Victoreen, Inc.
Radiology · 65d
Cleared Nov 12, 1993
REVO CLASSIC/SHAPES SUNGLASSES
K934400 · HQY
Revo, Inc.
Ophthalmic · 64d
Cleared Nov 12, 1993
ALL-VUE & GAMMA-VUE VIAL SHIELDS
K934548 · IWW
Victoreen, Inc.
Radiology · 51d
Cleared Nov 10, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · LIT
Boston Scientific Corp
Cardiovascular · 440d
Cleared Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
K926362 · CGA
Heraeus Kulzer, Inc.
Chemistry · 324d
Cleared Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · CEC
Heraeus Kulzer, Inc.
Chemistry · 292d
Cleared Nov 10, 1993
AUTOBEAD THYROID UPTAKE
K930689 · KHO
Bio-Chem Laboratory Systems, Inc.
Chemistry · 273d
Cleared Nov 10, 1993
JARIT SURGICAL INSTRUMENTS
K931928 · GCJ
J. Jamner Surgical Instruments, Inc.
General & Plastic Surgery · 208d