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
128497–128520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 27, 1989
AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR
K890204 · LHI
Stedim, Inc.
General Hospital · 282d
Cleared Oct 27, 1989
AUTOMIX COMPOUNDER Y - ADAPTOR SET
K890205 · LHI
Stedim, Inc.
General Hospital · 282d
Cleared Oct 27, 1989
CURIETRON 192 HIGH DOSE RATE
K890799 · JAQ
Cis-Us, Inc.
Radiology · 252d
Cleared Oct 27, 1989
PHENYLALANINE (NINHYDRIN REACTION)
K891070 · JNB
Alpkem Corp.
Chemistry · 240d
Cleared Oct 27, 1989
HEDY PATIENT EXAMINATION GLOVES (LATEX)
K891671 · LYY
Hedd Industry Corp.
General Hospital · 221d
Cleared Oct 27, 1989
MIPRON/UMIPRON
K891689 · LLZ
Kontron Electronics
Radiology · 219d
Cleared Oct 27, 1989
MIP MR
K891692 · LLZ
Kontron Electronics
Radiology · 219d
Cleared Oct 27, 1989
VIEW 1000
K891695 · LLZ
Virtual Imaging
Radiology · 219d
Cleared Oct 27, 1989
MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS
K892397 · LLZ
Nuccardiac Software, Inc.
Radiology · 203d
Cleared Oct 27, 1989
EBS2605 INFANT HUGGER
K892705 · BTY
Equilibrated Bio Systems, Inc.
Anesthesiology · 196d
Cleared Oct 27, 1989
PALGARAPID
K892839 · ELW
Espe GmbH (Us)
Dental · 192d
Cleared Oct 27, 1989
PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR
K892886 · CBK
Percussionaire Corp.
Anesthesiology · 191d
Cleared Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
K893518 · LNH
Diasonics, Inc.
Radiology · 172d
Cleared Oct 27, 1989
H.U. I.V. DROP COUNTER
K893693 · FLN
Li-Lien Corp.
General Hospital · 164d