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
112201–112224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1993
PROFAST(R)-DENTURE ADHESIVE CREAM
K930336 · KGB
Fittydent-Altwirth & Schmitt GmbH
Anesthesiology · 214d
Cleared Aug 24, 1993
BISCO D/C CORE COMPOSITE
K930405 · EBF
Bisco, Inc.
Dental · 210d
Cleared Aug 24, 1993
LAPRA-TY* SUTURE CLIP
K931492 · FZP
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Aug 24, 1993
I.D.A. SYRINGES
K931632 · FMF
Pt Hasoon Chandra
General Hospital · 144d
Cleared Aug 24, 1993
PULPDENT DENTAL BOND ENHANCER 2-B
K931710 · KLE
Pulpdent Corp.
Dental · 140d
Cleared Aug 24, 1993
TRANSSEPTAL INTRODUCER SET
K932619 · DQY
Thomas Medical Products, Inc.
Cardiovascular · 84d
Cleared Aug 24, 1993
GLENROE PLASTIC BRACKET
K932920 · DYW
Glenroe Technologies
Dental · 70d
Cleared Aug 24, 1993
SRUGICAL RETRACTOR, MODIFICATION
K933049 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Aug 24, 1993
ROTABLATOR, MODIFICATION
K933238 · MCW
Heart Technology, Inc.
Cardiovascular · 70d
Cleared Aug 24, 1993
ENDOSCOPIC ANTI-FOG KIT, 100-302-00
K933520 · GCJ
Avail-Southwest Division
General & Plastic Surgery · 35d
Cleared Aug 23, 1993
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
K924737 · DXO
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 335d
Cleared Aug 23, 1993
TELEPULSE
K925040 · JEH
Biometrix , Ltd.
Anesthesiology · 322d
Cleared Aug 23, 1993
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)
K925524 · DPW
Cardio Metrics, Inc.
Cardiovascular · 294d
Cleared Aug 23, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K930104 · JIX
Schiapparelli Biosystems, Inc.
Chemistry · 224d
Cleared Aug 23, 1993
LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
K930198 · HQY
Forda (China) Optical Co.
Ophthalmic · 221d
Cleared Aug 23, 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · IZH
Elscint, Inc.
Radiology · 214d
Cleared Aug 23, 1993
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · GKZ
Coulter Corp.
Hematology · 182d
Cleared Aug 23, 1993
ELECTRA 1600C AUTOMATIC COAGULATION TIMER
K931206 · GKP
Medical Laboratory Automation...
Hematology · 166d
Cleared Aug 23, 1993
SPECTRUM MARK I SPECIAL PROCEDURES TABLE
K931563 · IXR
Spectrum X-Ray Corp.
Radiology · 146d
Cleared Aug 23, 1993
METHADONE METABOLITE EIA ASSAY
K931780 · DJR
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Aug 23, 1993
2000 X-RAY - TOMOGRAPHIC
K931815 · IZF
Imaging Sciences Intl., Inc.
Radiology · 137d
Cleared Aug 23, 1993
MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
K931882 · IXW
Alphatek Corp.
Radiology · 131d
Cleared Aug 23, 1993
AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
K931883 · IXW
Alphatek Corp.
Radiology · 131d
Cleared Aug 23, 1993
CASCADE M, CAT. NO. 1710
K931956 · GKP
Helena Laboratories
Hematology · 125d