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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
132985–133008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1988
DELFIA THYROXINE (T4) KIT
K883559 · CDX
Pharmacia, Inc.
Chemistry · 117d
Cleared Dec 14, 1988
PUMPETTE(TM)
K884111 · JKA
Helena Laboratories
Chemistry · 76d
Cleared Dec 14, 1988
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197 · JIT
Casco Standards
Chemistry · 69d
Cleared Dec 14, 1988
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884201 · CEE
Cyberfluor, Inc.
Chemistry · 69d
Cleared Dec 14, 1988
VERSABLOT
K884258 · KPA
American Bionetics, Inc.
Chemistry · 64d
Cleared Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Dec 14, 1988
TOTAL IRON BINDING CAPACITY TEST
K884649 · JQE
Sclavo, Inc.
Chemistry · 37d
Cleared Dec 13, 1988
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
K881841 · DSB
Buckman Co., Inc.
Cardiovascular · 225d
Cleared Dec 13, 1988
HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT
K882657 · DYB
Harbor Medical Devices, Inc.
Cardiovascular · 167d
Cleared Dec 13, 1988
LYME DISEASE IFA (IGG)
K883487 · LSR
Hillcrest Biologicals
Microbiology · 119d
Cleared Dec 13, 1988
IRRIGATION KIT
K883506 · KYZ
L H M Ent., Inc.
General Hospital · 118d
Cleared Dec 13, 1988
CATHETER, INTRAUTERINE AND INTRODUCER
K883832 · KXO
Telos Medical Corp.
Obstetrics & Gynecology · 95d
Cleared Dec 13, 1988
MANUAL PERCUSSOR CUPS
K883899 · BYI
Medical Components, Inc.
Anesthesiology · 89d
Cleared Dec 13, 1988
CFX 625
K883976 · IZO
Fischer Imaging Corp.
Radiology · 84d
Cleared Dec 13, 1988
SANIFIX
K883983 · KGX
Iberhospitex, S.A.
General & Plastic Surgery · 84d
Cleared Dec 13, 1988
COATEST PROTEIN C
K884058 · GGP
Kabivitrum, Inc.
Hematology · 78d
Cleared Dec 13, 1988
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
K884198 · DQX
Target Therapeutics
Cardiovascular · 68d
Cleared Dec 13, 1988
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · KRB
Abbott Laboratories
Cardiovascular · 61d
Cleared Dec 13, 1988
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · CBP
Sechrist Industries, Inc.
Anesthesiology · 43d
Cleared Dec 13, 1988
WASHER 500 MICROELISA SYSTEM
K884695 · JTC
Organon Teknika Corp.
Microbiology · 34d
Cleared Dec 12, 1988
SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K875187 · IYO
Shimadzu Corp.
Radiology · 356d
Cleared Dec 12, 1988
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K882289 · DSY
Aries Medical, Inc.
Cardiovascular · 194d
Cleared Dec 12, 1988
MIKADO AC 405
K883837 · CAW
Ivex Medical, Inc.
Anesthesiology · 91d
Cleared Dec 12, 1988
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888 · DXK
Advanced Biosearch Assn.
Cardiovascular · 88d