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
107617–107640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1994
OSTEO INTERLOCKING-COMPRESSION NAIL
K933340 · HSB
Osteo AG
Orthopedic · 357d
Cleared Jun 30, 1994
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
K933827 · FTL
Bioplexus Corp.
General & Plastic Surgery · 329d
Cleared Jun 30, 1994
CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE
K936101 · GXY
Conmedcorp
Neurology · 190d
Cleared Jun 30, 1994
SUNGLASSES
K940592 · HQY
Sunblue Intl., Inc.
Ophthalmic · 142d
Cleared Jun 30, 1994
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · JBP
International Technidyne Corp.
Hematology · 121d
Cleared Jun 30, 1994
DISPENS-O-DISC(TM) NITROCEFIN
K941016 · JTO
Difco Laboratories, Inc.
Microbiology · 119d
Cleared Jun 30, 1994
SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN
K941312 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 104d
Cleared Jun 30, 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509 · LJM
Bio-Rad
Immunology · 93d
Cleared Jun 30, 1994
HEMAGEN ACL IGA CALIBRATOR
K941840 · MID
Hemagen Diagnostics, Inc.
Immunology · 78d
Cleared Jun 30, 1994
SURGICAL ADHESIVE TAPE
K941943 · KGX
Raleigh Lions Clinic For the Blind, Inc.
General & Plastic Surgery · 70d
Cleared Jun 30, 1994
SUNGLASSES
K942039 · HQY
Valiente Co., Ltd.
Ophthalmic · 63d
Cleared Jun 30, 1994
CMV EARLY ANTIGEN TEST
K942171 · GQI
Neogenex
Microbiology · 56d
Cleared Jun 30, 1994
RSV ANTIGEN TEST
K942173 · LKT
Neogenex
Microbiology · 56d
Cleared Jun 30, 1994
INFLUENZA B ANITGEN TEST
K942174 · GNW
Neogenex
Microbiology · 56d
Cleared Jun 30, 1994
ENDOTRACHEAL TUBE HOLDER
K942395 · CBH
S.T.I. Medical Products Corp.
Anesthesiology · 42d
Cleared Jun 29, 1994
ALPHA SPINAL SYSTEM
K930515 · KWP
Alphatec Mfg., Inc.
Orthopedic · 513d
Cleared Jun 29, 1994
D-C-S SYSTEM
K930657 · KWP
Pina-Vertriebs
Orthopedic · 505d
Cleared Jun 29, 1994
SUPER-SIL
K940164 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 174d
Cleared Jun 29, 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · HRX
Smith & Nephew, Inc.
Orthopedic · 162d
Cleared Jun 29, 1994
TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS
K940554 · HRX
Tnco, Inc.
Orthopedic · 142d
Cleared Jun 29, 1994
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K941404 · DRL
Hogan & Hartson
Cardiovascular · 98d
Cleared Jun 29, 1994
EXTENSION SET WITH ANTI-SIPHON VALVE
K941445 · FPA
Pharmacia Deltec, Inc.
General Hospital · 97d
Cleared Jun 29, 1994
HEMO-O-LOK
K941972 · FZP
King & Spalding
General & Plastic Surgery · 68d
Cleared Jun 29, 1994
HYPERTONIC SALINE WET DRESSING - STERILE
K941999 · KMF
Trinity Laboratories, Inc.
General & Plastic Surgery · 65d