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
103585–103608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1995
LASER GAS MIXTURE
K951045 · GEX
Liquid Carbonic Industrial Gases
General & Plastic Surgery · 25d
Cleared Mar 31, 1995
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K951075 · ELW
S & C Polymer GmbH
Dental · 22d
Cleared Mar 31, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
K951111 · DZE
Lifecore Biomedical, Inc.
Dental · 21d
Cleared Mar 30, 1995
CAMINO VENTRICULAR DRAINAGE SYSTEM
K932769 · JXG
Camino Laboratories, Inc.
Neurology · 660d
Cleared Mar 30, 1995
ACCUSCREEN 17-HYDROXYPROGESTERONE
K934178 · JLX
Neometrics, Inc.
Chemistry · 580d
Cleared Mar 30, 1995
FOUNDATION NON-POROUS STEM
K935449 · JDI
Encore Orthopedics, Inc.
Orthopedic · 503d
Cleared Mar 30, 1995
OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
K942091 · CAD
Ohmeda Medical
Anesthesiology · 332d
Cleared Mar 30, 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE...
K945211 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 156d
Cleared Mar 30, 1995
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
K946387 · JJJ
Capintec, Inc.
Chemistry · 125d
Cleared Mar 30, 1995
CART, MODE NUMBER UDS-CART
K950016 · FEN
Laborie Medical Tech Corp.
Gastroenterology & Urology · 86d
Cleared Mar 30, 1995
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135 · DKZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Mar 30, 1995
HAND MASSAGE UNIT
K950400 · IRO
Ultrassage, Inc.
Physical Medicine · 57d
Cleared Mar 30, 1995
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K950496 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 52d
Cleared Mar 30, 1995
REP CHOLESTEROL PROFILE CONTROL
K950590 · JJX
Helena Laboratories
Chemistry · 49d
Cleared Mar 30, 1995
CARDIO REP LD CONTROL - CAT NO. 3325
K950801 · JJT
Helena Laboratories
Chemistry · 37d
Cleared Mar 30, 1995
ALKO TONOMETERED SALINE CONTROL
K950902 · JJS
Alko Diagnostic Corp.
Chemistry · 30d
Cleared Mar 29, 1995
CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
K931133 · HGM
Clinicomp, Inc.
Obstetrics & Gynecology · 754d
Cleared Mar 29, 1995
SPECTRUM(TM) MASK
K936047 · BZD
Respironics, Inc.
Anesthesiology · 464d
Cleared Mar 29, 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K943603 · HET
Aesculap, Inc.
Obstetrics & Gynecology · 247d
Cleared Mar 29, 1995
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL...
K944158 · DZE
Steri-Oss, Inc.
Dental · 215d
Cleared Mar 29, 1995
SUREWING
K944824 · FPA
Gainor Medical U.S.A., Inc.
General Hospital · 181d
Cleared Mar 29, 1995
LANDMARK MIDLINE CATHETER
K944968 · FOZ
Menlo Care, Inc.
General Hospital · 169d
Cleared Mar 29, 1995
CORDIS AVANTI CATHETER SHEATH INTRODUCER
K945616 · DYB
Cordis Corp.
Cardiovascular · 134d
Cleared Mar 29, 1995
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE...
K945720 · DWC
Jostra Bentley
Cardiovascular · 128d