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
90889–90912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1997
BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED,...
K973682 · GEI
Electroscope, Inc.
General & Plastic Surgery · 83d
Cleared Dec 18, 1997
AQUA PATCH
K973693 · MGQ
Pci Technology
General & Plastic Surgery · 83d
Cleared Dec 18, 1997
DIGITAL ADD ON MULTI SYSTEM
K973710 · KPR
Swissray International, Inc.
Radiology · 80d
Cleared Dec 18, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973913 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Dec 18, 1997
DASH, VITAL GARD
K974114 · LZA
Dash Medical Gloves Sdn Bhd
General Hospital · 48d
Cleared Dec 18, 1997
VINYL PATIENT EXAMINATION GLOVES (POWDERED)
K974151 · LYZ
Shanghai Super Gloves Co., Ltd.
General Hospital · 44d
Cleared Dec 18, 1997
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
K974164 · FFK
Medical Device Consultants, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES
K974218 · LYY
Ansell Perry
General Hospital · 38d
Cleared Dec 18, 1997
NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
K974223 · LZA
Derlin Company , Ltd.
General Hospital · 36d
Cleared Dec 18, 1997
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE...
K974396 · CHL
Diametrics Medical, Inc.
Hematology · 27d
Cleared Dec 18, 1997
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454 · OCT
Tucson Medical Corp.
Gastroenterology & Urology · 23d
Cleared Dec 18, 1997
STERITITE SEALED CONTAINERS MODEL SCO4Q
K974638 · FRG
Case Medical, Inc.
General Hospital · 69d
Cleared Dec 17, 1997
THERMO-STAT SYSTEM
K970367 · DWJ
Aquarius Medical Corp.
Cardiovascular · 320d
Cleared Dec 17, 1997
MPORT FOLDABLE LENS PLACEMENT SYSTEM
K970727 · MSS
Chiron Vision Corp.
Ophthalmic · 292d
Cleared Dec 17, 1997
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · MML
Ipax, Inc.
Ophthalmic · 259d
Cleared Dec 17, 1997
KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM)
K971790 · IYN
Urometrics, Inc.
Radiology · 217d
Cleared Dec 17, 1997
LACTEST I
K971944 · KHP
Jwt, Inc.
Chemistry · 204d
Cleared Dec 17, 1997
SUPERSKIN
K972081 · NEC
Medlogic Global Corp.
General & Plastic Surgery · 197d
Cleared Dec 17, 1997
PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
K972192 · IYO
Perception, Inc.
Radiology · 190d
Cleared Dec 17, 1997
DENT-TEMP ACRYLIC
K972198 · EBG
Health-Dent Intl., Inc.
Dental · 189d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972633 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 156d