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
133057–133080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1989
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
K884816 · LNH
Diasonics, Inc.
Radiology · 77d
Cleared Feb 02, 1989
BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV
K884848 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30
K884850 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.
K884852 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
K884853 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
DADE PROTEIN C CHROMOGENIC ASSAY
K884881 · GGP
Baxter Healthcare Corp
Hematology · 72d
Cleared Feb 02, 1989
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K884886 · LDM
The Perkin-Elmer Corp.
Chemistry · 72d
Cleared Feb 02, 1989
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · GGN
Baxter Healthcare Corp
Hematology · 71d
Cleared Feb 02, 1989
T-UPTAKE MICROASSAY
K885034 · CEE
Diamedix Corp.
Chemistry · 59d
Cleared Feb 02, 1989
IMMUNODOT RUBELLA TEST
K885082 · LFX
General Biometrics, Inc.
Microbiology · 55d
Cleared Feb 02, 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
K885144 · CKA
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Feb 02, 1989
CLINISTAT SGOT (AST) REAGENT TEST
K885156 · CIT
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Feb 02, 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350 · DTB
Telectronics, Inc.
Cardiovascular · 86d
Cleared Feb 01, 1989
AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
K881857 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 274d
Cleared Feb 01, 1989
LACEY POSTERIOR STABILIZED KNEE SYSTEM
K884338 · JWH
Dow Corning Wright
Orthopedic · 110d
Cleared Feb 01, 1989
EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.
K884614 · DQA
Edentec Corp.
Anesthesiology · 89d
Cleared Feb 01, 1989
MVL/MODULAB WITH PVR MODULE
K884624 · JOM
Life Sciences Manufacturing, Inc.
Cardiovascular · 89d
Cleared Feb 01, 1989
CATH-FINDER SYSTEM
K884701 · FOZ
Pharmacia Deltec, Inc.
General Hospital · 84d
Cleared Feb 01, 1989
MICROVASIVE GOLD PROBE
K885005 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 62d
Cleared Feb 01, 1989
COI 24 HR COLLAGEN SHIELD
K885016 · MOE
Chiron Ophthalmics
Ophthalmic · 58d
Cleared Jan 31, 1989
CUDDLE UP PILLOW
K882544 · FRP
Ohio Medical Instrument Co., Inc.
General Hospital · 224d
Cleared Jan 31, 1989
URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450
K882714 · EYZ
Lsl Industries, Inc.
Gastroenterology & Urology · 214d
Cleared Jan 31, 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999 · LFX
Organon Teknika Corp.
Microbiology · 197d
Cleared Jan 31, 1989
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS
K883748 · FJI
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 152d