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
82369–82392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402,...
K000112 · EIA
Dentsply Intl.
Dental · 90d
Cleared Apr 13, 2000
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
K000117 · HEE
Avid Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 13, 2000
CTC DVT-1 CALF GARMENT, MODEL DVT-1
K000147 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 86d
Cleared Apr 13, 2000
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
K000168 · MHX
Datex-Ohmeda
Cardiovascular · 84d
Cleared Apr 13, 2000
CORTEK MINI LAPAROSCOPE
K000199 · HET
Cortek Endoscopy, Inc.
Obstetrics & Gynecology · 83d
Cleared Apr 13, 2000
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
K000206 · DRX
Axelgaard Mfg. Co., Ltd.
Cardiovascular · 83d
Cleared Apr 13, 2000
HARDYDISK, CEPHALOTHIN 30MCG
K000526 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 13, 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON...
K000570 · LIT
Boston Scientific Corp
Cardiovascular · 51d
Cleared Apr 13, 2000
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
K000646 · FBK
Enteric Medical Technologies
Gastroenterology & Urology · 48d
Cleared Apr 13, 2000
RANDOX PREALBUMIN
K000661 · JZJ
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Apr 13, 2000
QUALITROL LIPID CONTROL, LEVELS 1 AND 2
K000810 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 31d
Cleared Apr 13, 2000
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
K000824 · DYB
Medamicus, Inc.
Cardiovascular · 30d
Cleared Apr 13, 2000
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
K000829 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Apr 13, 2000
TFX MEDICAL STYLET CATHETER
K992664 · DRB
Tfx Medical Group
Cardiovascular · 248d
Cleared Apr 13, 2000
LEMAITRE OCCLUSION CATHETER
K992942 · MJN
Vascutech, Inc.
Cardiovascular · 226d
Cleared Apr 13, 2000
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
K993608 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 171d
Cleared Apr 13, 2000
LIGA-LOOP SUTURE APPLICATOR
K993695 · GAL
Hysterx, Inc.
General & Plastic Surgery · 163d
Cleared Apr 13, 2000
ACTIVATOR PASTE
K994027 · ELW
Harry J. Bosworth Co.
Dental · 139d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · LDJ
Roche Diagnostics Corp.
Toxicology · 126d
Cleared Apr 13, 2000
BAYER PSA ASSAY
K994221 · LTJ
Bayer Corp.
Immunology · 120d
Cleared Apr 13, 2000
EX 45-BP, MODEL 330 132
K994240 · DTB
Biotronik, Inc.
Cardiovascular · 119d
Cleared Apr 12, 2000
GSI 2000 MIDDLE EAR ANALYZER
K000097 · ETY
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 12, 2000
SOFTLINE SPRING CLIP
K000098 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 90d
Cleared Apr 12, 2000
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
K000105 · GZF
Medtronic Vascular
Neurology · 89d