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
129073–129096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1989
ANSWER DENTAL IMPLEMENTS, MIRROR
K894895 · EKJ
Tern Chien Ent. Co., Ltd.
Dental · 90d
Cleared Oct 30, 1989
ANSWER DENTAL IMPLEMENT, EXPLORER
K894896 · EKJ
Tern Chien Ent. Co., Ltd.
Dental · 90d
Cleared Oct 30, 1989
ANSWER DENTAL IMPLEMENT, FORCEPS
K894897 · EKJ
Tern Chien Ent. Co., Ltd.
Dental · 90d
Cleared Oct 30, 1989
990 GOLD
K894924 · EJT
Comprehensive Holistic Dentistry
Dental · 89d
Cleared Oct 30, 1989
AEROVENT
K894969 · BZA
Monaghan Medical Corp.
Anesthesiology · 84d
Cleared Oct 30, 1989
RESPITRACE PLUS
K894973 · FLS
Hogan & Hartson
Anesthesiology · 84d
Cleared Oct 30, 1989
PRESTO DIAGNOSTIC SPIROMETER
K894997 · BZG
Tamarac Systems Corp.
Anesthesiology · 83d
Cleared Oct 30, 1989
BAXTER BAFFLED TEE ADAPTER
K895014 · BZA
Baxter Healthcare Corp
Anesthesiology · 83d
Cleared Oct 30, 1989
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
K895031 · BZD
Ackrad Laboratories
Anesthesiology · 83d
Cleared Oct 30, 1989
BIOPSY FORCEPS
K895098 · DWZ
Annex Medical, Inc.
Cardiovascular · 76d
Cleared Oct 30, 1989
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122 · LJC
Ciba Corning Diagnostics Corp.
Microbiology · 76d
Cleared Oct 30, 1989
VISTA MR 2055 HP SYSTEM
K895151 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Oct 30, 1989
TTS2800
K895161 · GZJ
Henley Intl.
Neurology · 69d
Cleared Oct 30, 1989
TTS2500
K895166 · GZJ
Henley Intl.
Neurology · 69d
Cleared Oct 30, 1989
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K895211 · GZJ
Henley Intl.
Neurology · 73d
Cleared Oct 30, 1989
VMA EIA KIT YAMASA
K895287 · CDF
Yamasa Shoy Co., Ltd.
Chemistry · 66d
Cleared Oct 30, 1989
TTS2600
K895334 · GZJ
Henley Intl.
Neurology · 61d
Cleared Oct 30, 1989
BIRD (IPV) NONCONTINUOUS VENTILATORS
K895485 · NHJ
Percussionaire Corp.
Anesthesiology · 49d
Cleared Oct 30, 1989
N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT
K895572 · DLJ
Tudor Laboratories, Inc.
Toxicology · 54d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN CALIBRATOR SET
K895826 · DLJ
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN REAGENT SET
K895828 · LCS
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Oct 30, 1989
CREATININE 340 (ENZYMATIC)
K895847 · CGX
Sclavo, Inc.
Chemistry · 27d
Cleared Oct 30, 1989
LARYNGOSTAT LARYNGOSCOPE HANDLE
K895954 · CCW
Michigan Instruments, Inc.
Anesthesiology · 19d
Cleared Oct 30, 1989
FASTEC 901 AGGLUTINATION PATTERN READER
K895967 · JJQ
Schiff & Co.
Microbiology · 18d