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
103657–103680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1995
ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES
K946377 · GEI
Ximed Medical Systems
General & Plastic Surgery · 95d
Cleared Mar 24, 1995
CANDELA RUBY LAZE Q-SWITCHED RUBY LASER
K946386 · GEX
Candela Laser Corp.
General & Plastic Surgery · 93d
Cleared Mar 24, 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · MGP
Conmedcorp
General & Plastic Surgery · 74d
Cleared Mar 24, 1995
FUTURA ONE
K950187 · EJT
Degussa Corp.
Dental · 66d
Cleared Mar 24, 1995
IVID
K950200 · FPK
Scott/Ross Designs, Inc.
General Hospital · 65d
Cleared Mar 24, 1995
KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER
K950313 · GEX
Optomedic Medical Technologies , Ltd.
General & Plastic Surgery · 57d
Cleared Mar 24, 1995
HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER
K950344 · FCM
Acacia Laboratories, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 24, 1995
THEMALATOR. MODELS T-4-S, T-8-S, ETC.
K950350 · IRQ
Whitehall/Div Columbus Mckennon Corp.
Physical Medicine · 53d
Cleared Mar 24, 1995
CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)
K950351 · GEX
Ion Laser Technology
General & Plastic Surgery · 53d
Cleared Mar 24, 1995
CURAGEL HYDROGEL WOUND DRESSING
K950412 · NAE
Kendall Healthcare Products Co....
General & Plastic Surgery · 52d
Cleared Mar 24, 1995
GOLD K AMP ULTRA MINI CANAL
K950459 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 24, 1995
GOLD CD ULTRA MINI CANAL
K950460 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 24, 1995
ID400 SERIES ARMBOARDS
K950631 · JAA
Image Diagnostics, Inc.
Radiology · 39d
Cleared Mar 24, 1995
WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER
K950701 · IMA
Wahl Clipper Corp.
Physical Medicine · 37d
Cleared Mar 24, 1995
REDFIELD INFRARED COAGULATOR
K950836 · KNS
Hogan & Hartson
Gastroenterology & Urology · 28d
Cleared Mar 24, 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 24, 1995
RITE-BITE BIOPSY FORCEPS
K951051 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 18d
Cleared Mar 24, 1995
CATHETER SECUREMENT DEVICE
K951092 · BSO
Baxter Healthcare Corp
Anesthesiology · 15d
Cleared Mar 24, 1995
KAB SYSTEM
K951093 · BSF
King Systems Corp.
Anesthesiology · 15d
Cleared Mar 24, 1995
DRAGER MEDICAL AIR COMPRESSOR
K951126 · BTL
Drager, Inc.
Anesthesiology · 11d
Cleared Mar 24, 1995
HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULE
K951127 · CCK
Hewlett-Packard GmbH
Anesthesiology · 11d
Cleared Mar 24, 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K951173 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 9d
Cleared Mar 23, 1995
ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
K935235 · GCM
Smith & Nephew Richards, Inc.
Gastroenterology & Urology · 507d
Cleared Mar 23, 1995
ASPIRE
K936110 · BZH
Dura Pharmaceuticals, Inc.
Anesthesiology · 455d