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
135289–135312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1988
RPMI-1640 MEDIUM, CATALOG NO. 200-2076
K882808 · KIT
J R Scientific
Pathology · 11d
Cleared Jul 15, 1988
MEDSURG ACUTE DIALYSIS TRAY
K880778 · LFJ
Medsurg Industries, Inc.
Gastroenterology & Urology · 140d
Cleared Jul 15, 1988
AMDENT MODEL 830 ULTRASONIC SCALER
K880940 · ELC
Pathway Products, Inc.
Dental · 130d
Cleared Jul 15, 1988
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
K880979 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 129d
Cleared Jul 15, 1988
ACKRAD H/S PROCEDURE TRAY
K881680 · HIG
Ackrad Laboratories
Obstetrics & Gynecology · 87d
Cleared Jul 15, 1988
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · ETN
Downs Surgical , Ltd.
Ear, Nose, Throat · 81d
Cleared Jul 15, 1988
MULTI-FLEX TABLE--MODEL 200
K881804 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 78d
Cleared Jul 15, 1988
PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT
K881890 · EMA
Specialites Septodont
Dental · 71d
Cleared Jul 15, 1988
COVER UP
K881914 · EMA
Parkell
Dental · 67d
Cleared Jul 15, 1988
LIGHT-CURED ZIONOMER CEMENT
K881918 · EMA
Den-Mat Corp.
Dental · 67d
Cleared Jul 15, 1988
JEDMED MAXIM ENT CABINET
K881958 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 66d
Cleared Jul 15, 1988
NOSE BRACE
K882131 · LWF
Allied Advanced Technologies (Aat)
Ear, Nose, Throat · 56d
Cleared Jul 15, 1988
AMORPHUS SILK BY DENTRAX
K882400 · EBF
Dale T. Dupuis
Dental · 35d
Cleared Jul 15, 1988
ACID ETCH GEL
K882576 · EBF
Pulpdent Corp. of America
Dental · 23d
Cleared Jul 15, 1988
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
K882634 · HOX
Vistech Consultants, Inc.
Ophthalmic · 18d
Cleared Jul 15, 1988
MODEL P20/P21 IN-THE-EAR HEARING AID
K882692 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 14, 1988
BUBBLE TRAP-FILTER CAT. NO B180F37
K873316 · DTM
American Omni Medical, Inc.
Cardiovascular · 330d
Cleared Jul 14, 1988
H-H FLUSHING RESERVOIR
K875287 · JXG
Holter-Hausner Intl.
Neurology · 198d
Cleared Jul 14, 1988
MTX GENERATOR
K880352 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 170d
Cleared Jul 14, 1988
RESUS-AID
K881065 · CAE
Applied Convergent Technologies, Inc.
Anesthesiology · 122d
Cleared Jul 14, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR
K881716 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 84d
Cleared Jul 14, 1988
WS 800R THERMAL ARRAY RECORDER
K881831 · DSF
Nihon Kohden America, Inc.
Cardiovascular · 76d
Cleared Jul 14, 1988
MAGNUM 800(TM) MANAGEMENT SYSTEM
K881844 · FNL
The Medical Group, Inc.
General Hospital · 73d
Cleared Jul 14, 1988
RESPIRONICS SUCTIONEASY
K882017 · BSY
Respironics, Inc.
Anesthesiology · 62d