FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132265–132288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1989
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE
K890307 · HDB
Neward Enterprises, Inc.
Obstetrics & Gynecology · 67d
Cleared Mar 31, 1989
INTRAVASCULAR ADMINISTRATION SET
K890340 · FPA
Multi-Med, Inc.
General Hospital · 67d
Cleared Mar 31, 1989
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453 · DWZ
Dlp, Inc.
Cardiovascular · 60d
Cleared Mar 31, 1989
THE SPANTRON FRAME FREEZE
K890477 · LMA
Spantron, Inc.
Radiology · 59d
Cleared Mar 31, 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · DPS
Marquette Electronics, Inc.
Cardiovascular · 59d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Mar 31, 1989
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
K890798 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVE, LATEX
K890971 · LYY
Yaung Jenn Co., Ltd.
General Hospital · 32d
Cleared Mar 31, 1989
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
K891251 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891307 · LYY
Five Star Rubber Products
General Hospital · 18d
Cleared Mar 31, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K891322 · LYY
Duflex Products Sdn. Bhd.
General Hospital · 18d
Cleared Mar 31, 1989
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K891328 · KMY
American Orthodontics
Dental · 21d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891368 · LYY
Zest Mark Industrial Co., Ltd.
General Hospital · 22d
Cleared Mar 31, 1989
ORTHODONTIC PLASTIC BRACKET
K891372 · DYW
American Orthodontics
Dental · 22d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891501 · LYY
Tan Chong Rubber Gloves Sdn Bhd
General Hospital · 15d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891546 · LYY
Ap Intl., Inc.
General Hospital · 14d
Cleared Mar 31, 1989
PERCUSSION HAMMER
K891571 · GWZ
Sandal Surgico
Neurology · 11d
Cleared Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Mar 30, 1989
MICRODELTA II
K885242 · IYX
Siemens Gammasonics, Inc.
Radiology · 98d
Cleared Mar 30, 1989
GENNY DENNY IV SHIELD
K885342 · FMK
Mercury Enterprises, Inc.
General & Plastic Surgery · 92d
Cleared Mar 30, 1989
PATIENT EXAMINATION GLOVE
K890591 · LYY
Marcon Rubber Industry Sdn. Bhd.
General Hospital · 52d
Cleared Mar 30, 1989
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K890724 · BZK
Bear Medical Systems, Inc.
Anesthesiology · 45d
Cleared Mar 29, 1989
SAFECON CONDOMS W/SPERMICIDAL LUBRICANT
K883524 · HIS
Quality Synthetics Intl, Inc.
Obstetrics & Gynecology · 224d
Cleared Mar 29, 1989
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 133d